510(k) K233448 ยท JXG Shunt, Central Nervous System And Components
Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
| Applicant | Integra Lifesciences Production Corporation, Mansfield MA, US |
| Decision | Substantially Equivalent, Dec 19, 2023 |
| Received | Oct 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2024 | Integra LifeSciences Corp. CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other Open, Classified |
JXG | None listed |
| Jun 12, 2024 | Integra LifeSciences Corp. CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) a Open, Classified |
JXG | None listed |
| Jun 12, 2024 | Integra LifeSciences Corp. CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospina Open, Classified |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.