Cleared Traditional

K935774 - CURITY FAST-CATH FEMALE CATHETER KIT
(FDA 510(k) Clearance)

K935774 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology device
Apr 1994
Decision
129d
Days
Class 1
Risk

K935774 is an FDA 510(k) clearance for the CURITY FAST-CATH FEMALE CATHETER KIT. This device is classified as a Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile (Class I - General Controls, product code EYT).

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 11, 1994, 129 days after receiving the submission on December 3, 1993.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K935774 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received December 03, 1993
Decision Date April 11, 1994
Days to Decision 129 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code EYT — Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Device Class Class I - General Controls
CFR Regulation 21 CFR 876.5250