D. Device II

FDA 510(k) K955742 · Yousef Daneshvar

Substantially Equivalent

510(k) numberK955742

Submission

Device name
D. Device II
Applicant
Yousef Daneshvar
Livonia, MI, US
Received
December 19, 1995
Decision date
August 12, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DXC – Clamp, Vascular
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

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K230281PicoclampDXC · Traditional Kono Seisakusho Co., Ltd.10/23/2023SE
K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional Compression Works, Inc.03/03/2023SE
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Questions and answers

When was D. Device II cleared by the FDA?

D. Device II (K955742) received a 510(k) decision of Substantially Equivalent on August 12, 1996, 237 days after the submission was received.

What is the product code of K955742?

The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.