The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Modified Sterilization Of Intra-art(tm) Coronary.
Device ID | K901815 |
510k Number | K901815 |
Device Name: | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY |
Classification | Dilator, Vessel, For Percutaneous Catheterization |
Applicant | PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
Contact | Wright,phd |
Correspondent | Wright,phd PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
Product Code | DRE |
CFR Regulation Number | 870.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-23 |
Decision Date | 1990-07-03 |