Who is the manufacturer of AMR-ACV CLAMPS?

Applied Medical Resources filed the 510(k) submission for AMR-ACV CLAMPS (K962668).

What is the FDA product code for AMR-ACV CLAMPS?

DXC. It is classified under 21 CFR 870.4450 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AMR-ACV CLAMPS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for AMR-ACV CLAMPS?

Applied Medical vascular clamp, model G5048 (K901565).

Who can help prepare an FDA 510(k) submission like AMR-ACV CLAMPS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AMR-ACV CLAMPS

K962668 · Applied Medical Resources · DXC · Nov 4, 1996 · Cardiovascular

Device Facts

Record ID	K962668
Device Name	AMR-ACV CLAMPS
Applicant	Applied Medical Resources
Product Code	DXC · Cardiovascular
Decision Date	Nov 4, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4450
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The AMR-ACV clamp is indicated for use as a clamp for partially occluding coronary vessels.

Device Story

Side-bite vascular clamp; reusable stainless steel body; disposable soft pad inserts; snap-fit attachment. Used by surgeons in clinical settings for partial vessel occlusion. Device provides atraumatic clamping; reduces profile compared to predicate. Benefits include vessel integrity maintenance during coronary procedures.

Clinical Evidence

Bench testing only; mechanical and biocompatibility tests performed to verify functional and structural integrity and material safety.

Technological Characteristics

Reusable stainless steel clamp body; disposable soft pad inserts; snap-fit mechanism; side-bite configuration; low-profile design.

Indications for Use

Indicated for partial occlusion of coronary vessels during surgical procedures.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

Applied Medical vascular clamp, model G5048 (K901565)

Related Devices

K991589 — FLEXIBLE VASCULAR CLAMP, VERSION 2 · Allegiance Healthcare Corp. · May 18, 1999
K092544 — INSTRUMED VASCULAR CLAMPS · Instrumed International, Inc. · Oct 26, 2009
K072834 — SIBEL SA VASCULAR CLAMP · Surgical Instruments Belgium SA · Jan 9, 2008
K123077 — VASCULAR CLAMPS · Hebumedical GmbH · May 14, 2013
K992640 — SLIMLINE SURGICAL CLAMP; SLIMLINE JAW INSERTS · Minumys Surgical, Inc. · Sep 8, 1999

Submission Summary (Full Text)

{0} K962668 NOV 4 1996 APPENDIX VIII 510(k) SUMMARY 510(k) NUMBER: PENDING SUBMITTED BY: Applied Medical Resources Corporation 26051 Merit Circle, Unit# 103 Laguna Hills, California 92653 (714) 582-6120 EXT. 310 CONTACT PERSON: Howard V. Rowe DATE OF PREPARATION: July 8, 1996 NAME OF DEVICE: Applied Medical Atraumax® Coronary Vascular Low Profile Clamps and Inserts. CLASSIFICATION NAME: Vascular Clamp TRADE NAME: Not Determined SUMMARY STATEMENT: The AMR Atraumax® Coronary Vascular (ACV) low profile clamps and inserts are a line extension to an existing Applied Medical vascular clamp, model G5048. The G5048 clamp was previously approved under K901565. Differences between the ACV clamp and the predicate G5048 clamp include an expansion of the line to 5 models with sizes ranging from 45mm to 100mm and a reduction in the clamp profile. The AMR-ACV clamps are by design substantially equivalent to the G5048 clamp. The AMR-ACV clamp is indicated for use as a clamp for partially occluding coronary vessels. The AMR-ACV clamp is of a side-bite configuration and consists of a reusable stainless steel clamp body and a set of disposable soft pad inserts. Inserts mount to the clamp via a snap fit. Mechanical and biocompatibility tests were performed to verify functional and structural integrity and material safety. All testing has demonstrated that the AMR ACV Clamp is comparable to the predicate device and introduces no new safety and effectiveness issues when used as indicated. 21