The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Impco Disposable Aortic Punch.
| Device ID | K780247 |
| 510k Number | K780247 |
| Device Name: | IMPCO DISPOSABLE AORTIC PUNCH |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | THORATEC LABORATORIES CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-02-13 |
| Decision Date | 1978-02-27 |