510(k) K261004 · JXG Shunt, Central Nervous System And Components
Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)
| Applicant | Integra Lifesciences Production Corporation, Mansfield MA, US |
| Decision | Substantially Equivalent, Jun 23, 2026 |
| Received | Mar 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261004
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.