The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Intra-art(tm) Coronary Artery Occluders (ster).
| Device ID | K882879 |
| 510k Number | K882879 |
| Device Name: | PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) |
| Classification | Clamp, Vascular |
| 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 | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-11 |
| Decision Date | 1988-09-12 |