BIOCARDIA MORPH SHEATH GUIDE
FDA 510(k) clearance K090999 · decided 2009-04-15
Clearance details
- K-number
- K090999
- Device name
- BIOCARDIA MORPH SHEATH GUIDE
- Applicant
- Biocardia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-08
- Decision date
- 2009-04-15
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Carlos, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. recall (Z-1301-2014) | Biocardia, Inc. | 2014-03-27 |
| Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only recall (Z-1302-2014) | Biocardia, Inc. | 2014-03-27 |
| MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unop recall (Z-0991-2014) | Biocardia, Inc. | 2014-02-19 |