The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Modified Sterilization Method Of Pti Heart-lift.
| Device ID | K893436 |
| 510k Number | K893436 |
| Device Name: | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Wright,phd |
| Correspondent | Wright,phd PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-03 |
| Decision Date | 1989-07-14 |