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Safe-Cath

by Scientific Device Manufacturer, LLC

510(k) K960764

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 NumberK960764 Date24 Apr 1997ClearedStatusActive

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  • Withdrawn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, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Safe-Cath is a Class 2 General Hospital vascular access catheter. It is substantially equivalent to currently marketed vascular access catheters in intended use, materials, dimensions, and mechanical properties.

The device is manufactured by Scientific Device Manufacturer, LLC and cleared through the FDA Traditional 510(k) pathway under K960764 with product code FOZ. It is supplied as a single-use device for general hospital vascular access procedures.

Other devices from Scientific Device Manufacturer, LLC

Questions

AI-generated answers, 6 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 Safe-Cath device used for?

    Safe-Cath is a Class 2 General Hospital vascular access catheter intended for vascular access procedures in hospital settings, as it is substantially equivalent to marketed catheters in use, materials, dimensions, and mechanical properties.

  • How is the Safe-Cath supplied and is it reusable?

    Safe-Cath is supplied as a single-use device, meaning it is intended for one procedure only and should not be reused, reprocessed, or resterilized after initial use to ensure patient safety and device integrity.

  • What regulatory pathway was used for Safe-Cath clearance?

    Safe-Cath was cleared through the FDA Traditional 510(k) pathway under submission K960764, demonstrating substantial equivalence to a predicate device in intended use, materials, dimensions, and mechanical properties.