PTFE Super Sheath Introducer 2.1

Introducer, Catheter

MEDCOMP (MEDICAL COMPONENTS, INC.)

The following data is part of a premarket notification filed by Medcomp (medical Components, Inc.) with the FDA for Ptfe Super Sheath Introducer 2.1.

Pre-market Notification Details

Device IDK153246
510k NumberK153246
Device Name:PTFE Super Sheath Introducer 2.1
ClassificationIntroducer, Catheter
Applicant MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville,  PA  19438
ContactCourtney Nix
CorrespondentCourtney Nix
MEDCOMP (MEDICAL COMPONENTS, INC.) 1499 DELP DR. Harleysville,  PA  19438
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-09
Decision Date2016-02-12
Summary:summary

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