RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CALIFORNIA MEDICAL LABORATORIES, INC.

The following data is part of a premarket notification filed by California Medical Laboratories, Inc. with the FDA for Retrograde Cardioplegia Cannula, Self-inflating, With Malleable Or Guidewire Stylet.

Pre-market Notification Details

Device IDK002019
510k NumberK002019
Device Name:RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine,  CA  92614
ContactMehmet Bicakci
CorrespondentMehmet Bicakci
CALIFORNIA MEDICAL LABORATORIES, INC. 2681 KELVIN AVE. Irvine,  CA  92614
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-07-03
Decision Date2001-03-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10803622128216 K002019 000
10803622105262 K002019 000
10803622105279 K002019 000
10803622105309 K002019 000
10803622105316 K002019 000
10803622105323 K002019 000
10803622105330 K002019 000
10803622105347 K002019 000
10803622105354 K002019 000
10803622128193 K002019 000
10803622128209 K002019 000
10803622105255 K002019 000

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