The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Advance Enforcer 35 Focal Force Pta Balloon Catheter.
| Device ID | K141322 |
| 510k Number | K141322 |
| Device Name: | ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | COOK INCORPORATED 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Steven Lawrie |
| Correspondent | Steven Lawrie COOK INCORPORATED 750 DANIELS WAY P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2015-03-27 |
| Summary: | summary |