VP SHEATH

Catheter, Percutaneous

FLOWCARDIA, INC.

The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Vp Sheath.

Pre-market Notification Details

Device IDK051580
510k NumberK051580
Device Name:VP SHEATH
ClassificationCatheter, Percutaneous
Applicant FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
ContactRichard Spano
CorrespondentRichard Spano
FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale,  CA  94085
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-15
Decision Date2005-10-31

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