Shunt, Central Nervous System And Components
Regulation 882.5550
4510(k)s in 12 months (260 all time)
1recalls in 12 months (108 all time)
103recalls that name a 510(k)
Top companies in JXG
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neurosurgery | 18 | 49 |
| Codman & Shurtleff, Inc. | 23 | 19 |
| Integra LifeSciences Corporation | 14 | 21 |
| Holter-Hausner Intl. | 21 | 0 |
| Aesculap, Inc. | 14 | 6 |
| Cordis Corp. | 18 | 0 |
| Pudenz-Schulte Medical Research Corp. | 18 | 0 |
| Phoenix Biomedical | 11 | 1 |
| Radionics, Inc. | 10 | 0 |
| Sophysa | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K792007 K874498 +2 |
| 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 | K792007 K874498 +2 |
| 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 | K792007 K874498 +2 |
| 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 | K792007 K874498 +2 |
| 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 | K792007 K874498 +2 |
| 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 | K792007 K874498 +2 |
| Dec 12, 2008 | Integra LifeSciences Corp. Gravity Compensating Accessory;
High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory.
Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France;
distributed by: Integra Neu Terminated |
JXG | K932429 |
| Jul 20, 2004 | Phoenix Biomedical Cruciform Slit Valve Terminated |
JXG | K790126 K853363 |
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