Skip to content

Euromed S-601

by Lectec Corp.

510(k) K862765

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 NumberK862765 Date6 Aug 1986ClearedStatusActive

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  • Withdrawn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
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Euromed S-601 is a cardiovascular device that received FDA 510(k) clearance as substantially equivalent to a predicate device. It is identified by the product code DRX and K number K862765.

The device was cleared through a traditional 510(k) pathway, with the application received on July 22, 1986, and a decision issued on August 6, 1986. Manufactured by Lectec Corp. in Minnetonka, Minnesota, it is authorized for distribution in the United States.

Other devices from Lectec Corp.

See all devices from Lectec Corp. →