510(k) K021899 ยท DQY Catheter, Percutaneous
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
| Applicant | Concentric Medical, Inc., Moutian View CA, US |
| Decision | Substantially Equivalent, Jul 10, 2002 |
| Received | Jun 10, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2011 | Concentric Medical Inc Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA
Product is indicated for use in facilitating th Terminated |
GBS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.