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Schneider Pink Power Softip Guidnig Catheter

by Boston Scientific Scimed, Inc.

510(k) K943622

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 NumberK943622 Date30 Nov 1994ClearedStatusActive

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  • Withdrawn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, 27 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 Schneider Pink Power Softip Guiding Catheter is an intravascular device used to facilitate the introduction of interventional tools into the vasculature. It is a type of guiding catheter, which is used to guide other devices through the blood vessels.

The Schneider Pink Power Softip Guiding Catheter is available in various sizes and is compatible with standard vascular access equipment. It requires careful handling to maintain sterility and functionality during procedures. The device has received FDA 510K clearance, as indicated by the K943622 clearance number.

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Questions

AI-generated answers, 27 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 is the Schneider Pink Power Softip Guiding Catheter used for?

    The Schneider Pink Power Softip Guiding Catheter is used to guide other devices through blood vessels, facilitating the introduction of interventional tools into the vasculature.

  • Is the Schneider Pink Power Softip Guiding Catheter sterile?

    The device requires careful handling to maintain sterility and functionality during procedures, implying it is supplied sterile or must be sterilized before use.

  • What sizes is the Schneider Pink Power Softip Guiding Catheter available in?

    The Schneider Pink Power Softip Guiding Catheter is available in various sizes to accommodate different patient needs and vascular access requirements.