CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W

Introducer, Catheter

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Captiva Blood Containment Device Cn100, Can19t71w.

Pre-market Notification Details

Device IDK031922
510k NumberK031922
Device Name:CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
ClassificationIntroducer, Catheter
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactJohn W Nicholson
CorrespondentJohn W Nicholson
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-23
Decision Date2003-10-01
Summary:summary

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