The following data is part of a premarket notification filed by Angioscore, Inc. with the FDA for Angiosculpt Pta Scoring Balloon Catheter.
Device ID | K112182 |
510k Number | K112182 |
Device Name: | ANGIOSCULPT PTA SCORING BALLOON CATHETER |
Classification | Catheter, Percutaneous, Cutting/scoring |
Applicant | ANGIOSCORE, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan ANGIOSCORE, INC. 555 THIRTEENTH STREET NW Washington, DC 20004 |
Product Code | PNO |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-28 |
Decision Date | 2011-08-26 |
Summary: | summary |