The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Annuloplasty Ring(sterile).
| Device ID | K905175 |
| 510k Number | K905175 |
| Device Name: | PTI ANNULOPLASTY RING(STERILE) |
| Classification | Ring, Annuloplasty |
| Applicant | PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Wright |
| Correspondent | Wright PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-19 |
| Decision Date | 1992-02-14 |