← Product Code [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC) · K962668

# AMR-ACV CLAMPS (K962668)

_Applied Medical Resources · DXC · Nov 4, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K962668

## Device Facts

- **Applicant:** Applied Medical Resources
- **Product Code:** [DXC](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC.md)
- **Decision Date:** Nov 4, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4450
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **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.

## Regulatory Identification

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

## Predicate Devices

- Applied Medical vascular clamp, model G5048 ([K901565](/device/K901565.md))

## Submission Summary (Full Text)

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>
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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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K962668](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DXC/K962668)

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