The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Anastomart(tm) Coronary Bypass Graft Markers/modif.
| Device ID | K922025 |
| 510k Number | K922025 |
| Device Name: | ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| 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 | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-07 |
| Decision Date | 1992-09-22 |