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RMI Vascular Tourniquet Kit

by Research Medical, Inc.

510(k) K910221

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 NumberK910221 Date16 May 1991ClearedStatusActive

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  • Withdrawn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
DXC
Device Class
Class II
Regulation
21 CFR Part 870.4450
Advisory Committee
Cardiovascular
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 RMI Vascular Tourniquet Kit is a sterile, single-use, disposable kit containing all necessary components to snare and secure catheters, cannulas and tubing. It is designed for vascular applications in medical procedures.

The kit is supplied as a sterile, single-use device and is not intended for reuse. It received FDA 510(k) clearance on May 16, 1991, with product code DXC and is manufactured by Research Medical, Inc.

Other devices from Research Medical, Inc.

See all devices from Research Medical, 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 RMI Vascular Tourniquet Kit used for?

    The RMI Vascular Tourniquet Kit is designed for vascular applications in medical procedures. It contains all necessary components to snare and secure catheters, cannulas and tubing during these procedures.

  • Is the RMI Vascular Tourniquet Kit reusable?

    No, the RMI Vascular Tourniquet Kit is supplied as a sterile, single-use device and is not intended for reuse. It should be discarded after one use to maintain sterility and ensure proper function.

  • What regulatory approval does the RMI Vascular Tourniquet Kit have?

    The RMI Vascular Tourniquet Kit received FDA 510(k) clearance on May 16, 1991, with product code DXC. It is manufactured by Research Medical, Inc. and is substantially equivalent to other devices in its class.

  • What components are included in the RMI Vascular Tourniquet Kit?

    The RMI Vascular Tourniquet Kit contains all necessary components to snare and secure catheters, cannulas and tubing for vascular applications. The specific components are detailed in the kit's packaging and instructions for use.