HI-TORQUE COMMAND GUIDE WIRE FAMILY

Wire, Guide, Catheter

ABBOTT VASCULAR INC.

The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Hi-torque Command Guide Wire Family.

Pre-market Notification Details

Device IDK122573
510k NumberK122573
Device Name:HI-TORQUE COMMAND GUIDE WIRE FAMILY
ClassificationWire, Guide, Catheter
Applicant ABBOTT VASCULAR INC. 26531 YNEZ ROAD, BUILDING G MALING P.O. 9018 Temecula,  CA  92590 -9018
ContactKay Setzer
CorrespondentKay Setzer
ABBOTT VASCULAR INC. 26531 YNEZ ROAD, BUILDING G MALING P.O. 9018 Temecula,  CA  92590 -9018
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-23
Decision Date2012-11-20
Summary:summary

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