ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
FDA 510(k) clearance K080151 · decided 2008-04-25
Clearance details
- K-number
- K080151
- Device name
- ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
- Applicant
- Angioscore, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-22
- Decision date
- 2008-04-25
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- PNO
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 4. recall (Z-0838-2011) | AngioScore Inc. | 2011-01-04 |
| AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5. recall (Z-0839-2011) | AngioScore Inc. | 2011-01-04 |
| AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6. recall (Z-0840-2011) | AngioScore Inc. | 2011-01-04 |
| AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0 recall (Z-0841-2011) | AngioScore Inc. | 2011-01-04 |
| AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0 recall (Z-0842-2011) | AngioScore Inc. | 2011-01-04 |