510(k) K031123 ยท HCA Catheter, Ventricular
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, May 14, 2003 |
| Received | Apr 9, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031123
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.