F.A.S.T. SYSTEM SED AND CXD

Catheter, Embolectomy

GENESIS MEDICAL INTERVENTIONAL, INC.

The following data is part of a premarket notification filed by Genesis Medical Interventional, Inc. with the FDA for F.a.s.t. System Sed And Cxd.

Pre-market Notification Details

Device IDK092623
510k NumberK092623
Device Name:F.A.S.T. SYSTEM SED AND CXD
ClassificationCatheter, Embolectomy
Applicant GENESIS MEDICAL INTERVENTIONAL, INC. 3637 BERNAL AVENUE Pleasanton,  CA  94566
ContactAnne Worden
CorrespondentAnne Worden
GENESIS MEDICAL INTERVENTIONAL, INC. 3637 BERNAL AVENUE Pleasanton,  CA  94566
Product CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-26
Decision Date2009-10-30
Summary:summary

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