Per-Q-Cath Tray

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K831845 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Thora-Cath

  Class II

  FDA 510(k) K941232 Active Cleared 11 May 1994

• Gesco per-Q-Cath Repair Kit

  Class II

  FDA 510(k) K910622 Active Cleared 29 Mar 1991

• Umbili-Cath-S

  Class II

  FDA 510(k) K940953 Active Cleared 2 Aug 1994

• Gesco Catheterization Tray

  Class I

  FDA 510(k) K882647 Active Cleared 9 Sep 1988

• Gesco Dual Lumen Umbilicath II-DL

  Class II

  FDA 510(k) K896041 Active Cleared 17 Apr 1990

• Gesco per-Q-Cath Needle

  Class II

  FDA 510(k) K911215 Active Cleared 6 Jun 1991

See all devices from Gesco Intl., Inc. →

• What is the Per-Q-Cath Tray designed for?

  The Per-Q-Cath Tray is specifically designed for the sterile preparation and maintenance of long-term intravascular catheters (greater than 30 days). It provides a contained workspace to organize catheter components—such as tubing, connectors, and dressing materials—while minimizing contamination risk during clinical procedures. This helps maintain aseptic conditions, which is critical for preventing infections in patients with long-term catheter use.

• Is the Per-Q-Cath Tray single-use or reusable?

  The Per-Q-Cath Tray is intended for single-use in hospital settings, though clinical practices may vary regarding whether the tray itself is reusable or disposable. It is supplied to adhere to sterile processing protocols, ensuring safety and compliance with medical standards. Always follow facility-specific guidelines for tray reuse or disposal.

• How should the Per-Q-Cath Tray be stored?

  Storage of the Per-Q-Cath Tray follows standard sterile medical device protocols. This typically involves keeping it in a clean, dry environment, protected from dust, moisture, and direct sunlight. If the tray is supplied sterile, it should remain unopened until use to preserve sterility. Always refer to manufacturer instructions or facility policies for specific storage recommendations.

• What regulatory clearance does the Per-Q-Cath Tray hold?

  The Per-Q-Cath Tray holds FDA 510(k) clearance under the product code LJS, with a decision date of August 24, 1983. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets regulatory requirements for safety and effectiveness. No additional regulatory status is specified beyond this clearance.

• Are there specific size or model variations for the Per-Q-Cath Tray?

  The provided regulatory data does not specify size variations or distinct model references for the Per-Q-Cath Tray. It is classified under product code LJS for long-term intravascular catheters, but no MRI safety or size specifications are noted. For precise details on tray dimensions or model-specific features, consult the manufacturer’s documentation or contact Gesco Intl., Inc.