Disposable Optical Valvulotome

FDA 510(k) K924075 · Endovascular, Inc.

Substantially Equivalent

510(k) numberK924075

Submission

Device name
Disposable Optical Valvulotome
Applicant
Endovascular, Inc.
Costa Mesa, CA, US
Received
August 12, 1992
Decision date
February 8, 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
MGZ – Valvulotome
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4885
Specialty
Cardiovascular

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K132047Lemills ValvulotomeMGZ · Traditional LeMaitre Vascular, Inc.11/05/2013SE
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K111884Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special LeMaitre Vascular, Inc.07/29/2011SE
K080178Valvulotome by KovenMGZ · Traditional Koven Technology, Inc.07/28/2008SE

More from Koven Technology, Inc.

510(k)DeviceDecision
K931421Disposable Steerable AngioscopeLYK · Traditional 06/16/1993SE
K923996Disposable Vascular AngioscopeLYK · Traditional 01/13/1993SE

Questions and answers

When was Disposable Optical Valvulotome cleared by the FDA?

Disposable Optical Valvulotome (K924075) received a 510(k) decision of Substantially Equivalent on February 8, 1993, 180 days after the submission was received.

What is the product code of K924075?

The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.