Estech Arterial Remote Access Perfusion Cannula

Q: What is the product code of K990573?

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

FDA 510(k) K990573 · Estech, Inc.

Substantially Equivalent

510(k) numberK990573

Submission

Device name: Estech Arterial Remote Access Perfusion Cannula
Applicant: Estech, Inc.
Danville, CA, US
Received: February 23, 1999
Decision date: March 11, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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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K252772	Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional	Tz Medical, Inc.	05/22/2026SE
K254060	Life Saving TourniquetDXC · Traditional	TW Medical	04/03/2026SE
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K253070	Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional	Medline Industries, LP	11/20/2025SE
K232577	Radial Compression DeviceDXC · Traditional	Ningbo Dizegens Medical Science Co.,Ltd	01/18/2024SE
K230281	PicoclampDXC · Traditional	Kono Seisakusho Co., Ltd.	10/23/2023SE
K221661	Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional	Compression Works, Inc.	03/03/2023SE
K230248	ViolaDXC · Special	Vascular Graft Solutions, Ltd.	02/28/2023SE

510(k)	Device	Decision
K133017	Estech Cobra(R) Genesis Bipolar ClampGEI · Special	10/07/2013SE
K053021	Estech Clearview MV Atrial DepressorDTS · Traditional	01/26/2006SE
K052081	Remote Access Perfusion (Rap) Femoral Venous CannulaDWF · Traditional	12/16/2005SE
K051749	Cobra Surgical SystemGEI · Traditional	09/13/2005SE
K041599	Cobra Adhere Surgical SystemGEI · Traditional	07/27/2004SE
K032632	Remote Access Perfusion Cannula Left Axillary 21 FrenchDWF · Abbreviated	10/22/2003SE

Questions and answers

When was Estech Arterial Remote Access Perfusion Cannula cleared by the FDA?

Estech Arterial Remote Access Perfusion Cannula (K990573) received a 510(k) decision of Substantially Equivalent on March 11, 1999, 16 days after the submission was received.

What is the product code of K990573?

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