INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION

Introducer, Catheter

KONTRON INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Intra-aortic Balloon Pump Catheter - Modification.

Pre-market Notification Details

Device IDK923603
510k NumberK923603
Device Name:INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION
ClassificationIntroducer, Catheter
Applicant KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett,  MA  02149
ContactWayne P Grifgin
CorrespondentWayne P Grifgin
KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett,  MA  02149
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-02
Decision Date1993-03-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.