510(k) K083146 ยท DQX Wire, Guide, Catheter
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
| Applicant | Asahi Intecc Co., Ltd., Santa Ana CA, US |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Oct 23, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083146
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.