510(k) K080151 ยท PNO Catheter, Percutaneous, Cutting/Scoring
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
| Applicant | Angioscore, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Apr 25, 2008 |
| Received | Jan 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080151
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter;
OTW 0.018" Platform, 137 cm, 4.0 mm x 20 mm balloon size. Part (REF) number: 2076-4020 Terminated |
DQY | None listed |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5.0 mm x 20 mm balloon size, Part (REF) number: 2076-5020. Terminated |
DQY | None listed |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6.0 mm x 20 mm balloon size, Part (REF) number: 2076-6020. Terminated |
DQY | None listed |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2092-6020. Terminated |
DQY | None listed |
| Jan 4, 2011 | AngioScore Inc. AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0mm x 20 mm balloon size, Part (REF) number: 2105-6020 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.