Curity Fast-Cath Female Catheter Kit

Q: What is the product code of K935774?

The FDA product code is EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.

FDA 510(k) K935774 · Kendall Healthcare Products Co. Div.Of Tyco Health

Unknown

510(k) numberK935774

Submission

Device name: Curity Fast-Cath Female Catheter Kit
Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Mansfield, MA, US
Received: December 3, 1993
Decision date: April 11, 1994
Decision: Unknown (SEKD)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Device class: Class I (low risk)
Regulation: 21 CFR 876.5250
Specialty: Gastroenterology, Urology

Other 510(k)s with product code EYT

510(k)	Device	Applicant	Decision
K934080	Urinary Drainage BagEYT · Traditional	Kit Pak, Inc.	05/18/1994SE
K883119	Vpi Non-Adhesive Condom CatheterEYT · Traditional	Cook Urological, Inc.	08/02/1988SE
K883057	Comfort Cath Male External CatheterEYT · Traditional	Sierra Laboratories, Inc.	08/02/1988SE

More from Sierra Laboratories, Inc.

510(k)	Device	Decision
K973763	Kendall Curity Iodoform Packing StripEFQ · Traditional	12/31/1997SE
K973511	Kendall Curity Petrolatum GauzeFRO · Traditional	12/16/1997SN
K973507	Kendall Xeroform Petrolatum Dressing (6311,6312,6313,6314,6315,6316,6317)FRO · Traditional	12/15/1997SN
K973619	Kendall Curity Non-Adhering DressingKMF · Traditional	12/10/1997SN
K973509	Kendall Curasorb ZN + MG Alginate Wound DressingKMF · Traditional	12/04/1997SN
K973546	Kendall Fast-Cath Pre Lubricated Urethral CatheterEZD · Traditional	11/07/1997SE
K970266	Kendall Hydrophilic Powder Wound DressingKGN · Traditional	04/23/1997SN
K963446	Kendall Dual Lumen CatheterMPB · Traditional	03/18/1997SE
K964899	Kendall Curity Ureteral CatheterEYB · Traditional	02/07/1997SE
K964519	Curity Thoracentesis TrayGCX · Traditional	12/20/1996SE

Questions and answers

When was Curity Fast-Cath Female Catheter Kit cleared by the FDA?

Curity Fast-Cath Female Catheter Kit (K935774) received a 510(k) decision of Unknown on April 11, 1994, 129 days after the submission was received.

What is the product code of K935774?

The FDA product code is EYT – Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile, a Class I (low risk) device regulated under 21 CFR 876.5250.