MODIFIED ACUMEN SHEATH, MODEL TTWO767

Introducer, Catheter

ACUMEN MEDICAL, INC.

The following data is part of a premarket notification filed by Acumen Medical, Inc. with the FDA for Modified Acumen Sheath, Model Ttwo767.

Pre-market Notification Details

Device IDK050015
510k NumberK050015
Device Name:MODIFIED ACUMEN SHEATH, MODEL TTWO767
ClassificationIntroducer, Catheter
Applicant ACUMEN MEDICAL, INC. 1400 TERRA BELLA BLVD. SUITE A Mountain View,  CA  94043
ContactMarybeth Gamber
CorrespondentMarybeth Gamber
ACUMEN MEDICAL, INC. 1400 TERRA BELLA BLVD. SUITE A Mountain View,  CA  94043
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-04
Decision Date2005-02-03
Summary:summary

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