Devmed Double-Balloon Urological Catheter

FDA 510(k) K941488 · Medical Technology Development Corp.

Substantially Equivalent

510(k) numberK941488

Submission

Device name
Devmed Double-Balloon Urological Catheter
Applicant
Medical Technology Development Corp.
Santa Ynez, CA, US
Received
March 28, 1994
Decision date
November 30, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EZL – Catheter, Retention Type, Balloon
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5130
Specialty
Gastroenterology, Urology

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Questions and answers

When was Devmed Double-Balloon Urological Catheter cleared by the FDA?

Devmed Double-Balloon Urological Catheter (K941488) received a 510(k) decision of Substantially Equivalent on November 30, 1994, 247 days after the submission was received.

What is the product code of K941488?

The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.