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Louisville Clamp Product #65-172

by Edward Weck, Inc.

510(k) K770503

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770503 Date30 Mar 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a vascular clamp, classified under product code DXC as a Clamp, Vascular. It is intended for use in cardiovascular procedures to temporarily occlude blood flow during surgical interventions.

The Louisville Clamp Product #65-172 was cleared by the FDA through the traditional 510(k) pathway on March 30, 1977, under K770503. It is a Class II device subject to special controls, manufactured by Edward Weck, Inc. in McHenry, Illinois, United States.

Other devices from Edward Weck, Inc.

See all devices from Edward Weck, Inc. →

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Louisville Clamp Product #65-172 used for?

    The Louisville Clamp Product #65-172 is a vascular clamp intended for use in cardiovascular procedures to temporarily occlude blood flow during surgical interventions, as stated in its description.

  • How was the Louisville Clamp Product #65-172 authorized for market?

    The Louisville Clamp Product #65-172 was cleared by the FDA through the traditional 510(k) pathway on March 30, 1977, under submission K770503, as indicated in the authorizations and clearance details.

  • Who manufactures the Louisville Clamp Product #65-172 and where is it made?

    The Louisville Clamp Product #65-172 is manufactured by Edward Weck, Inc. in McHenry, Illinois, United States, as specified in the manufacturer and address fields.