510(k) K170599 ยท JXG Shunt, Central Nervous System And Components
SureFlo EVD Catheter
| Applicant | Arkis Biosciences, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Aug 31, 2017 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170599
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2026 | Integra LifeSciences Corp. (NeuroSciences) Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501.
The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverti Open, Classified |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.