CARDIOPULMONARY BYPASS PUMP TUBING

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

JTL MEDICAL CORP.

The following data is part of a premarket notification filed by Jtl Medical Corp. with the FDA for Cardiopulmonary Bypass Pump Tubing.

Pre-market Notification Details

Device IDK910021
510k NumberK910021
Device Name:CARDIOPULMONARY BYPASS PUMP TUBING
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant JTL MEDICAL CORP. 3410-F LA SIERRA SUITE 208 Riverside,  CA  92503
ContactJames Lichte
CorrespondentJames Lichte
JTL MEDICAL CORP. 3410-F LA SIERRA SUITE 208 Riverside,  CA  92503
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-03
Decision Date1991-05-22

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