VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

VAS-CATH, INC.

The following data is part of a premarket notification filed by Vas-cath, Inc. with the FDA for Vas-cath Inc. Opti-plast Angioplasty Catheter.

Pre-market Notification Details

Device IDK925485
510k NumberK925485
Device Name:VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER
ClassificationCatheter, Angioplasty, Peripheral, Transluminal
Applicant VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario,  CA L5a 3v3
ContactAngela J Acito
CorrespondentAngela J Acito
VAS-CATH, INC. 2380 TEDLO ST. Mississauga, Ontario,  CA L5a 3v3
Product CodeLIT  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-10-30
Decision Date1994-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.