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Walrus Percutaneous Introducer Set

by Medical Parameters, Inc.

510(k) K831239

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK831239 Date25 May 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DOY
Device Class
Class II
Regulation
21 CFR Part 862.3320
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

The Walrus Percutaneous Introducer Set is a medical device designed for the introduction of cardiovascular catheters or pacing leads through the skin and into a blood vessel. It functions as a conduit to facilitate the placement of these devices during clinical procedures.

This device is supplied by Medical Parameters, Inc. and has received FDA 510(k) clearance. It is categorized under product code DOY and regulation number 862.3320.

Other devices from Medical Parameters, Inc.