VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO

Wire, Guide, Catheter

FLOWCARDIA, INC.

The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Vp Wire Gw140st (.014 165cm, Standar), Model Gw140st; Vp Wire Gw140so (.014 165cm, Soft) Model Gw140so.

Pre-market Notification Details

Device IDK051062
510k NumberK051062
Device Name:VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
ClassificationWire, Guide, Catheter
Applicant FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
ContactRichard Spano
CorrespondentRichard Spano
FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-26
Decision Date2005-07-15
Summary:summary

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