The following data is part of a premarket notification filed by Spectranetrics with the FDA for Angiosculpt Pta Scoring Baloon Catheters.
| Device ID | K150634 |
| 510k Number | K150634 |
| Device Name: | AngioSculpt PTA Scoring Baloon Catheters |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | Spectranetrics 9965 Federal Drive Colorado Springs, CO 80921 |
| Contact | Kimberley Kline |
| Correspondent | Kimberley Kline Spectranetics 9965 Federal Drive Colorado Springs, CO 80921 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813132022242 | K150634 | 000 |
| 00813132022235 | K150634 | 000 |
| 00813132022228 | K150634 | 000 |
| 00813132022211 | K150634 | 000 |
| 00813132022204 | K150634 | 000 |
| 00813132022198 | K150634 | 000 |