Medical Components, Inc.

United States(FDA 510(k) applicant) Last updated 25 Oct 2026

Devices: 63
Registries: FDA 510(k)FDA
FDA recalls: 0

Catalogue63

Page 2 of 2

Medcomp Quad Lumen, 8.5F X 20cm, Model MC4L-8S Ref K010021

Class II FDA 510(k) Active
5F Dignity Ct Titanium Port Ref K130923

Class II FDA 510(k) Active
Medcomp Subclavian Catheter Ref K801672

Class II FDA 510(k) Active
Vasu-Picc Ref K122423

Class II FDA 510(k) Active
2F & 3F Vascu-Sheath Tearaway Introducer Ref K130687

Class II FDA 510(k) Active
Hemo-Cath Silicone Access Catheter Ref K915423

Class II FDA 510(k) Active
Hemo-Cath 10F, Hemo-Cath 12.5F Ref K113487

Class II FDA 510(k) Active
Medcomp Ultra-Flow Catheter Ref K003207

Class II FDA 510(k) Active
Roentgenography Set & Pressure Monitoring Line Ref K850861

Class II FDA 510(k) Active
Esophageal Stethescope Ref K800463

Class I FDA 510(k) Active
Medcomp H-Cath Triple Lumen Central Venous Access Catheter, Model Sic 12-3T Ref K983412

Class II FDA 510(k) Active
6F X 60cm Triple Pro-Line Ct Basic Ir Set Ref K131687

Class II FDA 510(k) Active
Hemo-Cath Ii Kidney Dialysis Catheter Ref K801966

Class II FDA 510(k) Active

Showing 51-63 of 63

FDA establishments1

Registered with the FDA under this company group, matched by name.

Medical Components Inc HARLEYSVILLE, PA · US FEI 2518902

About

eIFU and PIP are accessible in PDF format at www.medcomp.net/patientinformation© Medical Components, Inc. ● 1499 Delp Drive ● Harleysville, PA 19438 ● 215.256.4201

From the manufacturer's own website. Source

What Medical Components, Inc. makes

Medical Components, Inc. manufactures vascular catheter-related products, including nonimplantable introducer sets, securement devices, repair kits for catheters and lines, and valved peelable introducers designed for midline and peripheral access. Examples include catheter securement devices like the StatLock PICC Plus, repair kits for split stream and chronic Twinline systems, and power injectable sets for CT midlines. The company also supplies introducer needles and repair solutions for brands such as Tesio and Jet Medical.

The company’s products are classified under FDA categories including Class I, Class II, Class IIa, Class IIb, and Unclassified (U), with some devices listed in the EU’s eudamed registry and cleared via FDA’s 510(k) pathway. The manufacturer is based in Harleysville, Pennsylvania, USA.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Address: 3088 East 33rd Place, Yuma, AZ, 85365
Website: medcomp.net
LinkedIn: linkedin.com/company/medical-components-inc-
Facebook: facebook.com/medcomp
Email: [email protected]
Phone: +1(215)256-4201
FDA FEI number: 3013750125
DUNS number: 038000253

Catalogue63

Medcomp Quad Lumen, 8.5F X 20cm, Model MC4L-8S Ref K010021

5F Dignity Ct Titanium Port Ref K130923

Medcomp Subclavian Catheter Ref K801672

Vasu-Picc Ref K122423

2F & 3F Vascu-Sheath Tearaway Introducer Ref K130687

Hemo-Cath Silicone Access Catheter Ref K915423

Hemo-Cath 10F, Hemo-Cath 12.5F Ref K113487

Medcomp Ultra-Flow Catheter Ref K003207

Roentgenography Set & Pressure Monitoring Line Ref K850861

Esophageal Stethescope Ref K800463

Medcomp H-Cath Triple Lumen Central Venous Access Catheter, Model Sic 12-3T Ref K983412

6F X 60cm Triple Pro-Line Ct Basic Ir Set Ref K131687

Hemo-Cath Ii Kidney Dialysis Catheter Ref K801966

FDA establishments1

About

What Medical Components, Inc. makes

Information