The following data is part of a premarket notification filed by Angioscore, Inc. with the FDA for Angiosculpt Scoring Balloon Catheter.
| Device ID | K050629 |
| 510k Number | K050629 |
| Device Name: | ANGIOSCULPT SCORING BALLOON CATHETER |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | ANGIOSCORE, INC. 965 ATLANTIC AVE., SUITE 101 Alameda, CA 94501 |
| Contact | Gary Gershony |
| Correspondent | Gary Gershony ANGIOSCORE, INC. 965 ATLANTIC AVE., SUITE 101 Alameda, CA 94501 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-11 |
| Decision Date | 2005-09-02 |
| Summary: | summary |