CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

Ring, Annuloplasty

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Carpentier-edwards Physio Annuloplasty Ring.

Pre-market Notification Details

Device IDK926138
510k NumberK926138
Device Name:CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
ClassificationRing, Annuloplasty
Applicant BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
ContactRoberta Hines
CorrespondentRoberta Hines
BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana,  CA  92711
Product CodeKRH  
CFR Regulation Number870.3800 [🔎]
DecisionSe - Postmarket Surveillance Required (SESP)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-07
Decision Date1993-06-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00690103020298 K926138 000
00690103020281 K926138 000
00690103020274 K926138 000
00690103020267 K926138 000
00690103020250 K926138 000
00690103020243 K926138 000
00690103020236 K926138 000
00690103020229 K926138 000
00690103020212 K926138 000

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