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AMPLATZER TorqVue 45x45 Delivery Sheath

by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO

510(k) K163000

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 · Special NumberK163000 Date23 Dec 2016ClearedStatusActive

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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Amplatzer TorqVue 45x45 Delivery Sheath is a catheter-based delivery system designed for the deployment of vascular occlusion devices. It is classified as a Cardiovascular Occlusion Device and facilitates the precise placement of embolic agents or closure devices within blood vessels, such as atrial septal defects or patent foramen ovale.

This sheath is intended for use in interventional cardiology procedures, supplied sterile and intended for single-use. It features a 45-degree and 180-degree torque capability for enhanced device manipulation, with a 45x45 mm reference size. Compliance with FDA 510(k) clearance (K163000) ensures its regulatory approval for cardiovascular applications. Storage and handling follow sterile medical device protocols.

Questions

AI-generated answers, 1 Oct 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 Amplatzer TorqVue 45x45 Delivery Sheath used for?

    The Amplatzer TorqVue 45x45 Delivery Sheath is designed specifically for catheter-based deployment of vascular occlusion devices. It facilitates the precise placement of embolic agents or closure devices within blood vessels, such as those used to treat atrial septal defects (ASDs) or patent foramen ovale (PFO). Its torque capabilities—45° and 180°—allow clinicians to maneuver devices accurately during interventional cardiology procedures.

  • How is the Amplatzer TorqVue 45x45 Delivery Sheath supplied and intended for use?

    This delivery sheath is supplied sterile and is intended for single-use only. It adheres to standard sterile medical device protocols, ensuring safety and reliability for one-time procedural use. Reuse is not recommended to maintain sterility and performance.

  • What are the key specifications of the Amplatzer TorqVue 45x45 Delivery Sheath?

    The sheath features a 45x45 mm reference size, which corresponds to its dimensions for compatibility with specific occlusion devices. Its design includes torque control capabilities of 45° and 180°, enabling precise rotational adjustments during deployment. The sheath is classified under the FDA’s product code DQY (Cardiovascular Occlusion Device) and holds a 510(k) clearance (K163000).

  • How should the Amplatzer TorqVue 45x45 Delivery Sheath be stored?

    The sheath must be stored according to sterile medical device protocols to preserve its integrity and sterility. This includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring the seal remains intact until use. Always follow manufacturer guidelines for storage conditions to prevent contamination or damage.

  • Is the Amplatzer TorqVue 45x45 Delivery Sheath regulated by the FDA?

    Yes, the Amplatzer TorqVue 45x45 Delivery Sheath is regulated by the FDA and holds a 510(k) clearance (K163000). This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for its intended use in cardiovascular occlusion procedures.