Spectranetrics · Class II · Cleared Apr 8, 2015
| K-number | K150634 |
| Device name | AngioSculpt PTA Scoring Baloon Catheters |
| Applicant | Spectranetrics |
| Product code | PNO |
| Device class | Class II |
| Decision date | Apr 8, 2015 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov