Medcomp P-Cath

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K953811 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Raulerson One-Step Guidewire Insertion Bulb Needle

  Class II

  FDA 510(k) K971281 Active Cleared 9 Oct 1997

• Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)

  Class II

  FDA 510(k) K081904 Active Cleared 23 Sep 2008

• Medcomp Ash Split-Cath 28cm, Medcomp Ash Split-Cath 32cm

  Class II

  FDA 510(k) K972207 Active Cleared 23 Feb 1998

• Split Cath Rg

  Class II

  FDA 510(k) K130889 Active Cleared 28 Apr 2014

• Medcomp Split-Cath II

  Class II

  FDA 510(k) K040318 Active Cleared 3 Feb 2005

• Medcomp Split Cath II

  Class II

  FDA 510(k) K051280 Active Cleared 30 Nov 2005

See all devices from Medcomp →

• What is the Medcomp P-Cath used for?

  The Medcomp P-Cath is an intravascular catheter designed for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously into the patient's vascular system.

• How is the Medcomp P-Cath supplied and is it sterile?

  As an intravascular catheter, the Medcomp P-Cath is supplied sterile for single-use only, consistent with standard vascular access devices requiring aseptic insertion and short-term dwell time under 30 days.

• What regulatory pathway cleared the Medcomp P-Cath?

  The Medcomp P-Cath was cleared through the FDA 510(k) traditional pathway, received on July 26, 1995, and cleared on July 25, 1996, under product code FOZ as a substantially equivalent device.

• Who manufactures the Medcomp P-Cath and where is it located?

  The Medcomp P-Cath is manufactured by Medcomp, located at 1499 Delp Dr., Harleysville, PA 19438, United States, as listed in the FDA 510(k) submission.