510(k) K951258 ยท JXG Shunt, Central Nervous System And Components
PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
| Applicant | Pudenz-Schulte Medical Research Corp., Goleta CA, US |
| Decision | Substantially Equivalent, Sep 18, 1995 |
| Received | Mar 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951258
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers:
24048 - VALVE 24048 DELTA RGL PL 0.5,
24053 - CHAMBER 24053 DELTA,
24147 - VALVE 24147 DELTA SML P Open, Classified |
JXG | None listed |
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs:
22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW
22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L
22011 M - Open, Classified |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes:5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek plastic tray placed wi Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek plastic tray placed wit Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plastic tray placed withi Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240) 27782F. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plastic tray placed with Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek plastic tray placed wit Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is the Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pou Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed po Terminated |
JXG | None listed |
| Mar 27, 2009 | Medtronic Neurosurgery Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed po Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.