# Biocardia, Inc.

- Location (FDA's records): San Carlos, CA
- FDA decisions: 6 (2002–2024): 6 510(k) clearances
- Names in FDA's records: Biocardia, Inc. (4); Biocardia (2)
- Product codes: DYB (3), DQY (2), DQO (1)
- 510(k) review time since 2016: median 30 days, against 56 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 13 (4 its own); citations of its devices by later devices: 7 (4 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Scimed Life Systems, Inc.: 2 (https://510kreport.com/company/scimed-life-systems)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- Cardima, Inc.: 2 (https://510kreport.com/company/cardima)
- St. Jude Medical, Daig Division, Inc.: 1 (https://510kreport.com/company/st-jude-medical-daig-division)
- Enpath Medical, Inc.: 1 (https://510kreport.com/company/enpath-medical)
- Terumo Medical Corp.: 1 (https://510kreport.com/company/terumo-medical)

## Firms that cite its devices most
- Keystone Heart, Ltd.: 1 (https://510kreport.com/company/keystone-heart)
- Velocimed, Inc.: 1 (https://510kreport.com/company/velocimed)
- Edwards Lifesciences, LLC: 1 (https://510kreport.com/company/edwards-lifesciences)

## Its most-cited devices
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664 (2002), cited by 3
- K042553: Biocardia Morph Universal Deflectable Guide Catheter (2005), cited by 2
- K190941: BioCardia 8.5 F Avance Steerable lntroducer (2019), cited by 1
- K192774: BioCardia 8F Morph DNA Deflectable Guide Catheter (2020), cited by 1

## Recent decisions
- K242169: Morph DNA Steerable Introducer Sheath (Aug 23, 2024)
- K192774: BioCardia 8F Morph DNA Deflectable Guide Catheter (Jan 7, 2020)
- K190941: BioCardia 8.5 F Avance Steerable lntroducer (May 6, 2019)
- K090999: Biocardia Morph Sheath Guide (Apr 15, 2009)
- K042553: Biocardia Morph Universal Deflectable Guide Catheter (Feb 17, 2005)
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664 (Jan 24, 2002)

Source page: https://510kreport.com/company/biocardia