The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Heart-lift(tm) Cardiac Elevator (sterile).
| Device ID | K883135 |
| 510k Number | K883135 |
| Device Name: | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228 |
| Contact | Wright Phd |
| Correspondent | Wright Phd PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-26 |
| Decision Date | 1988-09-26 |