Atlas FDA

PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT

FDA 510(k) clearance K951258 · decided 1995-09-18

Clearance details

K-number
K951258
Device name
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
Applicant
Pudenz-Schulte Medical Research Corp.
Decision
Substantially Equivalent
Date received
1995-03-21
Decision date
1995-09-18
Days to decision
181 days
Clearance type
Traditional
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Goleta, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Si recall (Z-1124-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Si recall (Z-1125-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Si recall (Z-1126-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Si recall (Z-1127-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Si recall (Z-1128-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Si recall (Z-1129-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Si recall (Z-1130-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Si recall (Z-1131-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Si recall (Z-1132-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Si recall (Z-1133-2009)Medtronic Neurosurgery2009-03-27
Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Si recall (Z-1134-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter recall (Z-1135-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter recall (Z-1136-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter recall (Z-1137-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter recall (Z-1138-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter recall (Z-1139-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter recall (Z-1140-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter i recall (Z-1141-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter recall (Z-1142-2009)Medtronic Neurosurgery2009-03-27
Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter recall (Z-1143-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each recall (Z-1144-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each recall (Z-1145-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each recall (Z-1146-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each recall (Z-1147-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each recall (Z-1148-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each recall (Z-1149-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each recall (Z-1150-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Eac recall (Z-1151-2009)Medtronic Neurosurgery2009-03-27
Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Eac recall (Z-1152-2009)Medtronic Neurosurgery2009-03-27