Ventri-Cath

FDA 510(k) K931989 · Gesco Intl., Inc.

Substantially Equivalent

510(k) numberK931989

Submission

Device name
Ventri-Cath
Applicant
Gesco Intl., Inc.
San Antonio, TX, US
Received
April 22, 1993
Decision date
July 21, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JXG – Shunt, Central Nervous System And Components
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5550
Specialty
Neurology
Implant
Yes

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More from Aesculap, Inc.

510(k)DeviceDecision
K954422Per-Q-Cath Mid-LineLJS · Traditional 12/15/1995SE
K940953Umbili-Cath-SFOS · Traditional 08/02/1994SE
K940870Umbili-CathFOS · Traditional 08/02/1994SE
K940952Umbili-Cath-S-DlFOS · Traditional 07/29/1994SE
K941672Uri-Cath CatheterGBM · Traditional 05/16/1994SE
K941232Thora-CathJOL · Traditional 05/11/1994SE
K940871Umbili-Cath-PFOS · Traditional 04/29/1994SE
K926063Per-Q-Cath Dressing Change TrayMCY · Traditional 06/07/1993SEKD
K923591Pala-NateBTR · Traditional 03/16/1993SE
K915167Gesco Per-Q-Cath Catheter IntroducerDYB · Traditional 01/27/1992SE

Questions and answers

When was Ventri-Cath cleared by the FDA?

Ventri-Cath (K931989) received a 510(k) decision of Substantially Equivalent on July 21, 1993, 90 days after the submission was received.

What is the product code of K931989?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.