American Edwards Laboratories · Class II · Cleared Jan 13, 1981
| K-number | K803057 |
| Device name | FOGARTY BALLON ANGIOPLASTY CATHETERS |
| Applicant | American Edwards Laboratories |
| Product code | LIT |
| Device class | Class II |
| Decision date | Jan 13, 1981 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
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