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Terumo Radifocus Introducer Kit

by Terumo Medical Corp.

510(k) K863139

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863139 Date10 Oct 1986ClearedStatusActive

Official records

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  • Withdrawn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
DYB
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Terumo Radifocus Introducer Kit is a device designed for percutaneous insertion into blood vessels to facilitate interventional procedures. It is intended to provide stable vascular access during femoral interventions, from initial puncture to sheath removal.

The kit is supplied as a sterile, single-use system and is indicated for use in cardiovascular procedures. It received FDA 510(k) clearance under K863139 with product code DYB and was determined to be substantially equivalent to a predicate device. The device is manufactured by Terumo Medical Corp. and is intended for use in clinical settings requiring percutaneous vascular access.

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