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CPR Foley Catheter Kit

by Custom Pack Reliability 510(k)

Active United States

510(k) K960214

Overview

This device is a sterile urethral catheterization tray kit, designed for urinary catheterization procedures. It includes a Foley catheter, which is a flexible tube inserted into the bladder to drain urine, often used in medical settings requiring long-term drainage or post-operative care.

The CPR Foley Catheter Kit is supplied as a sterile, single-use device intended for use in clinical settings such as hospitals, urology clinics, and emergency rooms. It is classified under FDA regulation 876.5130 and has received a Traditional 510(k) clearance under the Gastroenterology and Urology advisory committees. The kit adheres to Class II medical device standards and is intended for one-time use per manufacturer specifications.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960214 Date1 Apr 1996ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Cpr Foley Cahteter Kit
510(k) Number
FDA Product Code
FCM
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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