HI-TORQUE WINN 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 Winn Guide Wire Family.

Pre-market Notification Details

Device IDK101648
510k NumberK101648
Device Name:HI-TORQUE WINN GUIDE WIRE FAMILY
ClassificationWire, Guide, Catheter
Applicant ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara,  CA  95054
ContactLaarni Ricafort
CorrespondentLaarni Ricafort
ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-06-11
Decision Date2010-07-08
Summary:summary

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