ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Rotating Hemo Valve - Dual Access Type.

Pre-market Notification Details

Device IDK861847
510k NumberK861847
Device Name:ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
ContactKevin Corrigan
CorrespondentKevin Corrigan
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. Temecula,  CA  92591
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-13
Decision Date1986-06-16

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