510(k) K081768
- Device
- COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
- Applicant
- COOK INCORPORATED
- 510(k) number
- K081768
- Product code
- NAJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-23
- Date received
- 2008-06-20
- Regulation
- 870.3300
- Classification name
- Agents, Embolic, For Treatment Of Uterine Fibroids
- Medical specialty
- Cardiovascular
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSANNE GALIN
- Address
- 750 Daniels Way Bloomington IN US 47404 47404
FDA Registration Numbers#
- 9615728
- 3009756327
- 3002124543
- 2134265
- 3010173425
- 9616684
- 3010178296
- 3006950086
- 3005111382
- 2124215
- 3002807295
- 3002807314
- 1721504
- 3008262715
- 1820334
- 3031240343
- 3004859241
- 3013556777
- 1225687
Source Documents#
Other 510(k) Records For Product Code NAJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233813 | Bearing nsPVA Express™ | Merit Medical Systems, Inc. | 2023-12-21 |
| K173871 | CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 |
| K133447 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES | Celonova Biosciences, Inc. | 2014-02-24 |
| K130259 | BEARING NSPVA EMBOLIZATION PARTICLES | Merit Medical Systems, Inc. | 2013-06-07 |
| K100663 | CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 | Boston Scientific Corporation | 2010-04-16 |
| K030966 | CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER | Boston Scientific Corp | 2003-09-23 |
| K021397 | EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION | Biosphere Medical, Inc. | 2002-11-22 |
Legacy Summary#
summary
FDA Review#
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