Daneshvar's Device (Modification)

FDA 510(k) K961461 · Y. Daneshvar

Substantially Equivalent

510(k) numberK961461

Submission

Device name
Daneshvar's Device (Modification)
Applicant
Y. Daneshvar
Livonia, MI, US
Received
April 2, 1996
Decision date
June 26, 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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More from Vascular Graft Solutions, Ltd.

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K955827Daneshvar Wound Support UnitDXC · Traditional 10/02/1996SE
K935494Daneshvar's DeviceDXC · Traditional 11/22/1994SE

Questions and answers

When was Daneshvar's Device (Modification) cleared by the FDA?

Daneshvar's Device (Modification) (K961461) received a 510(k) decision of Substantially Equivalent on June 26, 1996, 85 days after the submission was received.

What is the product code of K961461?

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