EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
FDA 510(k) clearance K021397 · decided 2002-11-22
Clearance details
- K-number
- K021397
- Device name
- EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
- Applicant
- Biosphere Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-02
- Decision date
- 2002-11-22
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- NAJ
- Device class
- 2
- Regulation number
- 870.3300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bearing nsPVA Express™ (K233813) | Merit Medical Systems, Inc. | 2023-12-21 |
| CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (K173871) | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 |
| EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (K133447) | Celonova Biosciences, Inc. | 2014-02-24 |
| BEARING NSPVA EMBOLIZATION PARTICLES (K130259) | Merit Medical Systems, Inc. | 2013-06-07 |
| CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (K100663) | Boston Scientific Corporation | 2010-04-16 |
| COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (K081768) | Cook Incorporated | 2008-12-23 |
| CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (K030966) | Boston Scientific Corp | 2003-09-23 |
Recalls involving this device
No recalls on record reference this clearance.