REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET

Introducer, Catheter

REMINGTON MEDICAL, INC.

The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Dispos Tear-away Vasc Intro Set.

Pre-market Notification Details

Device IDK932370
510k NumberK932370
Device Name:REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET
ClassificationIntroducer, Catheter
Applicant REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta,  GA  30350
ContactFrederick L.aycock
CorrespondentFrederick L.aycock
REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta,  GA  30350
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-14
Decision Date1993-11-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20813079020213 K932370 000
10813079020209 K932370 000
20813079020190 K932370 000
10813079020186 K932370 000
10813079020179 K932370 000
10813079020162 K932370 000

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