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Piton(Tm) Y-Pack and Piton(Tm) Tri-Pack)

by Medtronics Interventional Vascular

510(k) K945461

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 NumberK945461 Date3 Feb 1995ClearedStatusActive

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  • Withdrawn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
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
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.

The PITON Y-PACK and PITON TRI-PACK are devices classified as adaptors, stopcocks, manifolds, fittings, and cardiopulmonary bypass components. They are intended for use in medical applications related to cardiovascular procedures.

These devices are supplied as single-use items and are intended for use in clinical settings. They are not reusable and are not marked as MRI safe. The device is regulated under FDA 510(k) clearance and is not explicitly stated to be sterile in the provided data.

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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 are the PITON Y-PACK and TRI-PACK used for?

    These devices are classified as adaptors, stopcocks, manifolds, fittings, and cardiopulmonary bypass components. They are intended for use in medical applications related to cardiovascular procedures.

  • Are the PITON Y-PACK and TRI-PACK sterile?

    The device is not explicitly stated to be sterile in the provided data. They are supplied as single-use items intended for use in clinical settings.

  • Can the PITON Y-PACK and TRI-PACK be reused?

    No, these devices are supplied as single-use items and are not reusable.

  • Is the PITON Y-PACK and TRI-PACK MRI safe?

    No, the device is not marked as MRI safe.