RESPONSE(TM) STEERABLE CATHETER

Catheter, Steerable

DAIG CORP.

The following data is part of a premarket notification filed by Daig Corp. with the FDA for Response(tm) Steerable Catheter.

Pre-market Notification Details

Device IDK913940
510k NumberK913940
Device Name:RESPONSE(TM) STEERABLE CATHETER
ClassificationCatheter, Steerable
Applicant DAIG CORP. 14901 DEVEAU PLACE Minnetonka,  MN  55345 -2126
ContactJ Fleischhacker
CorrespondentJ Fleischhacker
DAIG CORP. 14901 DEVEAU PLACE Minnetonka,  MN  55345 -2126
Product CodeDRA  
CFR Regulation Number870.1280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-03
Decision Date1993-01-26

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