DiscCath Needle Set

Needle, Conduction, Anesthetic (w/wo Introducer)

DiscCath LLC

The following data is part of a premarket notification filed by Disccath Llc with the FDA for Disccath Needle Set.

Pre-market Notification Details

Device IDK212328
510k NumberK212328
Device Name:DiscCath Needle Set
ClassificationNeedle, Conduction, Anesthetic (w/wo Introducer)
Applicant DiscCath LLC 62 E 88th Street New York,  NY  10128
ContactGregory E. Lutz
CorrespondentGregory E. Lutz
DiscCath LLC 62 E 88th Street New York,  NY  10128
Product CodeBSP  
CFR Regulation Number868.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-27
Decision Date2021-09-26

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