EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
FDA 510(k) clearance K133447 · decided 2014-02-24
Clearance details
- K-number
- K133447
- Device name
- EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
- Applicant
- Celonova Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-12
- Decision date
- 2014-02-24
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- NAJ
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COBRA PzF NanoCoated Coronary Stent System (P160014/S018) | Celonova Biosciences, Inc. | 2021-10-12 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S017) | Celonova Biosciences, Inc. | 2020-11-19 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S015) | Celonova Biosciences, Inc. | 2020-06-18 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S016) | Celonova Biosciences, Inc. | 2020-04-27 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S010) | Celonova Biosciences, Inc. | 2020-03-29 |
| Cobra PzF NanoCoated Coronary Stent System (P160014/S009) | Celonova Biosciences, Inc. | 2019-12-24 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S012) | Celonova Biosciences, Inc. | 2019-12-06 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S013) | Celonova Biosciences, Inc. | 2019-11-07 |