INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)

Introducer, Catheter

INNERDYNE, INC.

The following data is part of a premarket notification filed by Innerdyne, Inc. with the FDA for Innerdyne Radially Expanding Vascular Access System (revas).

Pre-market Notification Details

Device IDK992668
510k NumberK992668
Device Name:INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
ClassificationIntroducer, Catheter
Applicant INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
ContactRick Gaykowski
CorrespondentRick Gaykowski
INNERDYNE, INC. 5060 WEST AMELIA EARHART DR. Salt Lake City,  UT  84116
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-09
Decision Date2000-05-26
Summary:summary

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