Medical Components IV Catheter

510(k) Number

K800525 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Duo Flow Catheter-Mc 54

  Class II

  FDA 510(k) K842416 Active Cleared 26 Jul 1984

• MCSCP8PS with 'y' Hub

  Class II

  FDA 510(k) K821684 Active Cleared 24 Jun 1982

• Twin Silicone Catheter

  Class II

  FDA 510(k) K923691 Active Cleared 25 Sep 1995

• Medicomp Flexi-Smooth Wound Drainage Catheter

  Class I

  FDA 510(k) K960426 Active Cleared 21 Mar 1996

• 1.9F X 20cm Vascu-Picc 1.9F X 50cm Vascu-Picc

  Class II

  FDA 510(k) K120980 Active Cleared 2 May 2012

• Double Lumen Sublcavian-Femoral

  Class II

  FDA 510(k) K841530 Active Cleared 25 Jun 1984

See all devices from Medical Components, Inc. →

• What types of medical settings is this IV catheter approved for use in?

  This IV catheter is specifically cleared for use in hospital settings under FDA 510(k) clearance (K800525). The clearance falls under the General Hospital advisory committee, indicating its intended application is within clinical environments where intravenous access is required for administering fluids, medications, or blood products.

• Is this IV catheter reusable or meant for single-use, and how should it be stored?

  The catheter is intended for single-use only and is supplied sterile. To maintain sterility, it must be stored under the manufacturer-recommended conditions, as specified by Medical Components, Inc. Improper storage could compromise its sterile integrity.

• What types of vascular access does this catheter support, and how is it classified?

  This catheter is designed for peripheral or central venous access, providing a reliable pathway for infusions of fluids, medications, or blood products. It is classified under FDA product code FOZ, which categorizes it as a general-purpose intravenous catheter.

• How do I know this catheter meets FDA standards, and what does the clearance number mean?

  This catheter holds an FDA 510(k) clearance (K800525), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. The clearance was issued under the General Hospital advisory committee (HO) in 1980, confirming its compliance with regulatory requirements for hospital-use intravenous catheters.