The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Intra-art Inter Mamm Artery Papaver Infus Kit.
| Device ID | K883221 |
| 510k Number | K883221 |
| Device Name: | PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228 |
| Contact | Wright |
| Correspondent | Wright PIONEERING TECHNOLOGIES, INC. 143 UNION BLVD., SUITE 900 Lakewood, CO 80228 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-29 |
| Decision Date | 1988-10-13 |