DELTA-FLOW

Catheter, Continuous Flush

TRI-DELTA INTL.

The following data is part of a premarket notification filed by Tri-delta Intl. with the FDA for Delta-flow.

Pre-market Notification Details

Device IDK780479
510k NumberK780479
Device Name:DELTA-FLOW
ClassificationCatheter, Continuous Flush
Applicant TRI-DELTA INTL. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-27
Decision Date1978-11-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H6719026371 K780479 000
H6711002051 K780479 000
H6711002041 K780479 000
H6711002021 K780479 000

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