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Guiding Catheter Hemostasis Valve Cap

by Arrow Intl., Inc.

510(k) K933033

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 NumberK933033 Date10 Sep 1993ClearedStatusActive

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  • Withdrawn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, 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.

A guiding catheter hemostasis valve cap is a device designed to maintain hemostasis at the insertion site of a guiding catheter during percutaneous cardiovascular procedures. It functions as a seal to prevent blood loss while allowing the passage of guidewires,ires or other instruments through the catheter lumen.

This device is supplied as a sterile, single-use component intended for use in cardiovascular interventional settings. It is authorized under FDA 510(k) clearance K933033 with product code DQY and is classified as a Class 2 device. No information regarding MRI safety, sizes, storage conditions, or reusability is provided in the data.

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Questions

AI-generated answers, 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.

  • What is the guiding catheter hemostasis valve cap used for?

    It is designed to maintain hemostasis at the insertion site of a guiding catheter during percutaneous cardiovascular procedures by preventing blood loss while allowing the passage of guidewires or other instruments through the catheter lumen.

  • Is the guiding catheter hemostasis valve cap sterile and single-use?

    Yes, the device is supplied as a sterile, single-use component intended for use in cardiovascular interventional settings, as specified in the device description.

  • What regulatory authorization does the guiding catheter hemostasis valve cap have?

    It is authorized under FDA 510(k) clearance K933033 with product code DQY and is classified as a Class 2 device, based on the provided device data.