Biocardia, Inc.
FDA Regulatory Profile
Biocardia, Inc. appears in FDA public data with 3 recalls, 6 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1301-2014, Class II) was initiated on March 3, 2014. Its most recent 510(k) clearance was granted on August 23, 2024.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 6
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1301-2014 | Class II | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCar | March 3, 2014 |
| Z-1302-2014 | Class II | Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. Bio | March 3, 2014 |
| Z-0991-2014 | Class II | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, un | February 7, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242169 | Morph DNA Steerable Introducer Sheath | August 23, 2024 |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | January 7, 2020 |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | May 6, 2019 |
| K090999 | BIOCARDIA MORPH SHEATH GUIDE | April 15, 2009 |
| K042553 | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER | February 17, 2005 |
| K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | January 24, 2002 |