MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

Dilator, Vessel, For Percutaneous Catheterization

PIONEERING TECHNOLOGIES, INC.

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.

Pre-market Notification Details

Device IDK901815
510k NumberK901815
Device Name:MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge,  CO  80033
ContactWright,phd
CorrespondentWright,phd
PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge,  CO  80033
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-04-23
Decision Date1990-07-03

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