Clampease Fa

FDA 510(k) K863427 · Freund Medical Products

Substantially Equivalent

510(k) numberK863427

Submission

Device name
Clampease Fa
Applicant
Freund Medical Products
Dayton, OH, US
Received
September 4, 1986
Decision date
November 20, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code DXC

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K262086PreludeSYNC™ Radial Compression DeviceDXC · Special Merit Medical Systems, Inc.07/22/2026SE
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K252772Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional Tz Medical, Inc.05/22/2026SE
K254060Life Saving TourniquetDXC · Traditional TW Medical04/03/2026SE
K243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional Arc Trauma, LLC12/31/2025SE
K253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional Medline Industries, LP11/20/2025SE
K232577Radial Compression DeviceDXC · Traditional Ningbo Dizegens Medical Science Co.,Ltd01/18/2024SE
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
K230248ViolaDXC · Special Vascular Graft Solutions, Ltd.02/28/2023SE

Questions and answers

When was Clampease Fa cleared by the FDA?

Clampease Fa (K863427) received a 510(k) decision of Substantially Equivalent on November 20, 1986, 77 days after the submission was received.

What is the product code of K863427?

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