C3 Wave System

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

Medical Components, Inc. (dba Medcomp)

The following data is part of a premarket notification filed by Medical Components, Inc. (dba Medcomp) with the FDA for C3 Wave System.

Pre-market Notification Details

Device IDK180567
510k NumberK180567
Device Name:C3 Wave System
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant Medical Components, Inc. (dba Medcomp) 1499 Delp Drive Harleysville,  PA  19438
ContactCourtney Nix
CorrespondentCourtney Nix
Medical Components, Inc. (dba Medcomp) 1499 Delp Drive Harleysville,  PA  19438
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-05
Decision Date2018-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15051684020862 K180567 000
15051684027236 K180567 000
H787MRC3RD0041 K180567 000
H787MRC3RD0031 K180567 000
H787MRC3RD0001 K180567 000
15051684027199 K180567 000
15051684027168 K180567 000
15051684029810 K180567 000
15051684029803 K180567 000
15051684027243 K180567 000
15051684027267 K180567 000
15051684027274 K180567 000
15051684020855 K180567 000
15051684027397 K180567 000
15051684027380 K180567 000
15051684027373 K180567 000
15051684027366 K180567 000
15051684027359 K180567 000
15051684027328 K180567 000
15051684027311 K180567 000
15051684029797 K180567 000

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