Permanent Silicone Catheters LFJ

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Permanent Silicone Catheters

510(k) Number

K910501 ↗

FDA Product Code

LFJ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Tenckhoff Peritoneal Dialysis Kit

  Class II

  FDA 510(k) K902203 Active Cleared 1 Aug 1990

• Fc-101 Femoral Catheter Guide Wire

  Class II

  FDA 510(k) K891764 Active Cleared 7 Apr 1989

• Dual Lumen Sub-Clavian Catheters Dlsc 600S & 800S

  Class II

  FDA 510(k) K900803 Active Cleared 25 Apr 1990

• Vessel Dilators

  Class II

  FDA 510(k) K910502 Active Cleared 29 Apr 1991

• Y Adaptor

  Class II

  FDA 510(k) K910321 Active Cleared 16 Apr 1991

• Introducer Needles

  Class II

  FDA 510(k) K910641 Active Cleared 29 Apr 1991

See all devices from Akcess Medical Products, Inc. →

• What is the Permanent Silicone LFJ Catheter designed for?

  The Permanent Silicone LFJ Catheter is specifically designed for long-term urinary drainage, intended for permanent placement within the urinary tract. Its purpose is to facilitate continuous urine flow, thereby reducing the risk of urinary retention and associated complications such as infection or irritation. The silicone material is chosen for its biocompatibility, minimizing irritation and infection risks over extended periods of use.

• How are these catheters supplied and intended for use?

  The Permanent Silicone LFJ Catheters are supplied sterile and are intended exclusively for single-use applications. This means each catheter is packaged in a sterile condition to ensure safety and efficacy when used in clinical settings such as hospitals or outpatient care facilities. Single-use design helps prevent cross-contamination and ensures patient safety.

• Are these catheters reusable, or are they meant for one-time use?

  These catheters are explicitly designed for single-use only. The sterile packaging and intended use guidelines emphasize that each catheter should be used once and then discarded. This approach aligns with best practices for infection control and patient safety in medical settings, particularly for devices intended for long-term placement within the body.

• What sizes or variations are available for the Permanent Silicone LFJ Catheters?

  The Permanent Silicone LFJ Catheters are referenced by the product code LFJ, which indicates a specific line of catheters. While the exact sizes are not detailed in the provided data, the product code suggests multiple variations may be available to accommodate different patient needs. For precise sizing information, refer to the manufacturer’s catalog or technical specifications.

• How should these catheters be stored before use?

  Since the catheters are supplied sterile, they must be stored in their original, unopened packaging to maintain sterility. Storage should follow the manufacturer’s guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or storage instructions before use to ensure optimal performance and safety.