ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW

Wire, Guide, Catheter

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Floppy/floppy Ii/inter./standard Gw.

Pre-market Notification Details

Device IDK881897
510k NumberK881897
Device Name:ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
ContactGary Johnson
CorrespondentGary Johnson
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-06
Decision Date1988-08-03

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