SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

SCHNEIDER-SHILLEY (USA)

The following data is part of a premarket notification filed by Schneider-shilley (usa) with the FDA for Softrac-pta(tm) Peripheral Dilatation Catheter.

Pre-market Notification Details

Device IDK881197
510k NumberK881197
Device Name:SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis,  MN  55441
ContactAnn H Morrissey
CorrespondentAnn H Morrissey
SCHNEIDER-SHILLEY (USA) 2905 NORTHWEST BLVD. Minneapolis,  MN  55441
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-21
Decision Date1988-05-16

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