510(k) K952638 ยท LYK Angioscope
4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[
| Applicant | Baxter Edwards, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jul 28, 1995 |
| Received | Jun 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952638
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.