Pharmaseal Rubber Urethral Catheter

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

510(k) Number

K874517 ↗

FDA Product Code

KOD

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Disposable Pressure Transducer

  Class II

  FDA 510(k) K830210 Active Cleared 18 Apr 1983

• Pharmaseal Over-the Needle Arterial Catheter & Sta

  Class II

  FDA 510(k) K853714 Active Cleared 13 Jan 1986

• Arteriogram Tray

  Class II

  FDA 510(k) K812927 Active Cleared 6 Nov 1981

• Pharmaseal Endoscopy Prep Kit Upper and Lower

  Class II

  FDA 510(k) K874045 Active Cleared 3 Dec 1987

• Thermodilution Kit

  Class II

  FDA 510(k) K811480 Active Cleared 9 Jun 1981

• Nasal Oxygen Catheter

  Class I

  FDA 510(k) K820370 Active Cleared 16 Apr 1982

See all devices from American Pharmaseal Div. Ahsc →

• What is the primary purpose of the Pharmaseal Rubber Urethral Catheter?

  This device is indicated for the drainage of urine from the bladder, serving as a urological tool for patients requiring assistance with bladder emptying.

• What is the regulatory classification of this catheter?

  The Pharmaseal Rubber Urethral Catheter is classified as a Class II medical device and is authorized under FDA 510(k) clearance K874517.

• Who is the manufacturer of this device?

  This catheter is manufactured by the American Pharmaseal Division of AHSC, located in Valencia, California.