510(k) K082580 ยท DYB Introducer, Catheter
SPECTRA GUIDEWIRE INTRODUCER NEEDLE
| Applicant | Spectra Medical Devices, Inc., Wilmington MA, US |
| Decision | Substantially Equivalent, Dec 8, 2008 |
| Received | Sep 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082580
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.