The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Intra-art(r) Coronary Artery Probe (sterile).
| Device ID | K891786 |
| 510k Number | K891786 |
| Device Name: | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) |
| Classification | Dilator, Vessel, Surgical |
| Applicant | PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Stephen Mckelvey |
| Correspondent | Stephen Mckelvey PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-24 |
| Decision Date | 1989-10-12 |