510(k) K082725 ยท GBX Catheter, Irrigation
GRAFTGUARD PRESSURE CONTROLLING SYRINGE
| Applicant | Maquet Cardiovascular, LLC, San Jose CA, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | Sep 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082725
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2023 | Maquet Cardiovascular, LLC Vasoshield Syringe Packs, Model VH-5001 Open, Classified |
GBX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.