Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.
The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.
The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.
The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.
The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.
The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

Recall details

Manufacturer

Integra Limited

Distributor

Nationwide Distribution

Lot

Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000233245, 305000233244, 305000233243, 305000233242, 305000233241, 305000233240, 30500X233415, 30500X234183, 305000233607, 305000233608, 30500X234806, 305000234303, 305000234304, 305000235022, 305000235017, 30500X235732, 305000235598, 30500X236328, 305000236105, 305000236104, 305000236655, 305000236653, 30500Y237087, 30500X237090, 305000237232, 30500X237761, 305000237824, 305000237825, 30500X238273, 305000238263, 305000238264, 30500X239095, 305000238818, 305000238819, 30500X239497, 30500X239748, 30500X239958, 30500X240334, 30500X240668, 30500X241368, 305000241516, 305000242236, 305000242792, 305000242795, 305000242796, 305000242794, 305000242793, 305000242791, 3050RY243869, 305000243251, 305000243882, 305000243881, 305000243888, 305000243889, 305000243883, 30500X244281, 30500X244880, 305000244513,30500X245306, 305000244481, 305000244480, 305000244934, 30500X245937, 30500X246067, 305000245408, 30500X246872, 305000245835, 30500X246951, 30500X247608, 305000246460, 30500X248284, 305000247007, 3050RX227127, 3050RX234303, 305000247717, 305000249072, 3050RX242794, 3050RX242793, 3050RX237825, 3050RX241516, 30500X249488, 305000248479, 30500X250423, 305000249743, 30500X250964, 305000250456, 30500X251060, 305000251055, 30500X251560, 30500X252133, 3050RY252136, 305000251453, 30500X252771, 305000252058, 3050RX244513, 305000252646, 305000253785, 30500X254929, 3050RY255145, 30500X255141, 305000254589, 305000255549, 305000255551, 305000255038, 30500X256614, 305000256192, 305000257281, 305000256709, 305000257280, 305000258048, 30500X259385, 305000258379, 305000258921, 305000258922, 30500X259557, 305000259431, 305000259432, 30500X260159, 305000259966, 305000259960, 305000260514, 305000260527, 30500Y261748, 3050RX253785, 305000261325, 305000261326, 305000261737, 305000261736, 3050RX256192, 30500X262441, 305000262328, 305000262327, 305000262978, 305000262977, 3050RY263508, 30500X263559, 305000263504, 305000264073, 305000264074, 3050002646

Risk classification

Class II

Area (FDA)

device

Country

United States