BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM

Clamp, Vascular

CARDIVA MEDICAL, INC.

The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Boomerang Catalyst/boomerang Catalyst Ii System.

Pre-market Notification Details

Device IDK072297
510k NumberK072297
Device Name:BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
ClassificationClamp, Vascular
Applicant CARDIVA MEDICAL, INC. 155 MOFFETT PARK DR., SUITE A-210 Sunnyvale,  CA  94089
ContactKit Cariquitan
CorrespondentKit Cariquitan
CARDIVA MEDICAL, INC. 155 MOFFETT PARK DR., SUITE A-210 Sunnyvale,  CA  94089
Product CodeDXC  
CFR Regulation Number870.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-17
Decision Date2007-09-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.