CATHETER, RADIOPAQUE TENCKHOFF

Catheter, Peritoneal, Long-term Indwelling

DRAVON MEDICAL, INC.

The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Catheter, Radiopaque Tenckhoff.

Pre-market Notification Details

Device IDK782057
510k NumberK782057
Device Name:CATHETER, RADIOPAQUE TENCKHOFF
ClassificationCatheter, Peritoneal, Long-term Indwelling
Applicant DRAVON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJS  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-07
Decision Date1979-02-27

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