The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Fogarty Ballon Angioplasty Catheters.
| Device ID | K803057 |
| 510k Number | K803057 |
| Device Name: | FOGARTY BALLON ANGIOPLASTY CATHETERS |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-02 |
| Decision Date | 1981-01-13 |