CARDIOTOMY RESERVOIR CR-2000

Permanent Pacemaker Electrode

DELTA MEDICAL INDUSTRIES

The following data is part of a premarket notification filed by Delta Medical Industries with the FDA for Cardiotomy Reservoir Cr-2000.

Pre-market Notification Details

Device IDK790116
510k NumberK790116
Device Name:CARDIOTOMY RESERVOIR CR-2000
ClassificationPermanent Pacemaker Electrode
Applicant DELTA MEDICAL INDUSTRIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDTB  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-22
Decision Date1979-02-08

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