510(k) K090999 ยท DYB Introducer, Catheter
BIOCARDIA MORPH SHEATH GUIDE
| Applicant | Biocardia, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Apr 15, 2009 |
| Received | Apr 8, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2014 | Biocardia, Inc. Morph AccessPro Steerable Introducer;
6F Introducer, 45 cm working length
Single use only.
BioCardia, Inc.
San Carlos, CA 94070
BioCardia Morph AccessPro is intended to provide a pathway through medi Terminated |
DYB | None listed |
| Mar 27, 2014 | Biocardia, Inc. Morph AccessPro Steerable Introducer;
6F Introducer, 90 cm working length:
Single use only.
BioCardia, Inc.
San Carlos, CA 94070
BioCardia Morph AccessPro is intended to provide a pathway through me Terminated |
DYB | None listed |
| Feb 19, 2014 | Biocardia, Inc. MORPH ACCESSPRO Steerable Introducer;
6F introducer, 90 cm working length:
Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic:
BioCardia Inc.
San Carlos, CA 94070
Intended to Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.