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Merit Safety Introducer Needle

by Merit Medical Systems, Inc.

510(k) K140513

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

Overview

The MERIT SAFETY INTRODUCER NEEDLE is a high-quality, FDA-cleared introducer needle designed for safe and effective placement of stents in patients with cardiovascular disease. Our device features a unique design that provides excellent control and maneuverability, making it ideal for complex procedures. With its proven track record of safety and efficacy, the MERIT SAFETY INTRODUCER NEEDLE is a trusted choice among healthcare professionals.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140513 Date9 Jul 2014ClearedStatusActive

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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