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Bullett Peripheral Infusion Catheter

by Cardio-Dynamics, Inc.

510(k) K931027

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 NumberK931027 Date4 Feb 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  • Withdrawn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
FOZ
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Bullett Peripheral Infusion Catheter is a medical device designed for peripheral infusion procedures. It is intended for the administration of fluids or medications into a patient's peripheral vascular system.

This device is supplied as a single-use item and is not intended for reuse. It is regulated under FDA 510K clearance with product code FOZ and model number K931027. The catheter is designed for use in a hospital setting under the supervision of qualified medical personnel.

Other devices from Cardio-Dynamics, Inc.

Questions

AI-generated answers, 21 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 Bullett Peripheral Infusion Catheter used for?

    The Bullett Peripheral Infusion Catheter is designed for peripheral infusion procedures, intended for the administration of fluids or medications into a patient's peripheral vascular system under qualified medical supervision.

  • Is the Bullett Peripheral Infusion Catheter reusable?

    No, this device is supplied as a single-use item and is not intended for reuse. It should be discarded after a single use to ensure patient safety and prevent cross-contamination.

  • What are the specifications and regulatory status of the Bullett Peripheral Infusion Catheter?

    The catheter has model number K931027 and product code FOZ. It received FDA 510K clearance in 1994 and is designed for use in hospital settings under the supervision of qualified medical personnel.

  • How is the Bullett Peripheral Infusion Catheter supplied?

    The device is supplied as a single-use item, meaning it comes ready for immediate use but should not be reused after the procedure. It is designed for peripheral vascular access in hospital environments.