Biocardia, Inc.
Medical device manufacturer in Sunnyvale, CA.
6510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K242169 | Morph DNA Steerable Introducer SheathDYB · Special | 08/23/2024SE |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide CatheterDQY · Special | 01/07/2020SE |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducerDYB · Traditional | 05/06/2019SE |
| K090999 | Biocardia Morph Sheath GuideDYB · Traditional | 04/15/2009SE |
| K042553 | Biocardia Morph Universal Deflectable Guide CatheterDQY · Traditional | 02/17/2005SE |
| K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664DQO · Traditional | 01/24/2002SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1302-2014 Class II | Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use…Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer… | 03/03/2014Terminated |
| Z-1301-2014 Class II | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use…Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer… | 03/03/2014Terminated |
| Z-0991-2014 Class II | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in…Tyvek packaging may be worn, causing loss of package integrity. | 02/07/2014Terminated |