Catheter, Ventricular
Regulation 882.4100
0510(k)s in 12 months (10 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in HCA
| Company | 510(k)s | Recalls |
|---|---|---|
| Codman & Shurtleff, Inc. | 3 | 1 |
| Vygon Neuro | 0 | 3 |
| Aesculap, Inc. | 1 | 0 |
| Bresagen, Inc. | 1 | 0 |
| Image-Guided Neurologics, Inc. | 1 | 0 |
| Innerspace, Inc. | 1 | 0 |
| Integra Life Sciences Corp. | 0 | 1 |
| Integra LifeSciences Corp. | 0 | 1 |
| Medtronic PS Medical | 1 | 0 |
| Mri Interventions, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2021 | Integra LifeSciences Corp. CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus.
Catalog Number: NS5524 Terminated |
HCA | K031123 |
| Jan 10, 2006 | Vygon Neuro 10 cm Scopable Catheter Reservoir Terminated |
HCA | K853361 K853362 |
| Jan 10, 2006 | Vygon Neuro 7 cm Catheter Reservoir with 10 cm extension Terminated |
HCA | K853361 K853362 |
| Jan 10, 2006 | Vygon Neuro 6 cm Catheter Reservoir with 10 cm extension Terminated |
HCA | K853361 K853362 |
| Jul 20, 2004 | Codman & Shurtleff, Inc. Codman Holter Salmon Rickham Reservoir with Ventricular Catheter
Catalog Number: 82-1617 Terminated |
HCA | None listed |
| Jul 20, 2004 | Integra Life Sciences Corp. Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one IN Terminated |
HCA | K961113 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.