Medical Device Manufacturer · US , Harleysville , PA

Medical Components, Inc. (dba MedComp)

9 submissions · 5 cleared · Since 2017
9
Total
5
Cleared
0
Denied

Medical Components, Inc. (dba MedComp) — FDA 510(k) Submissions

Medical Components, Inc. (dba MedComp) has submitted 9 FDA 510(k) premarket notifications since 2017, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Hemodialysis, Triple Lumen, Non-implanted, Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days, Catheter, Hemodialysis, Implanted, Midline Catheter, Catheter, Hemodialysis, Non-implanted . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Trio-CT?? Triple Lumen Catheter w/ Curved Extensions
K232945 · NIE Catheter, Hemodialysis,... · Gastroenterology & Urology
Nov 2023 57d
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
K202176 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
Sep 2020 30d
Duo-Flow Side x Side Double Lumen Catheter
K192807 · MPB Catheter, Hemodialysis,... · Gastroenterology & Urology
Apr 2020 205d
Trio-CT Triple Lumen Catheter
K183219 · NIE Catheter, Hemodialysis,... · Gastroenterology & Urology
Jun 2019 206d
12F Tri-Flow Triple Lumen Catheter
K181175 · NIE Catheter, Hemodialysis,... · Gastroenterology & Urology
Jul 2018 64d
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
K173667 · MSD Catheter, Hemodialysis,... · Gastroenterology & Urology
May 2018 168d
C3 Wave System
K180567 · LJS Catheter, Intravascular,... · General Hospital
Apr 2018 38d
C3 Wave System
K170934 · LJS Catheter, Intravascular,... · General Hospital
Dec 2017 251d
CT Midline
K170770 · PND Midline Catheter · General Hospital
Jul 2017 133d
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