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TEGWIRE

by Boston Scientific 2 variants

510(k) K913391

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 NumberK913391 Date5 Nov 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  • Withdrawn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)

Full name
Tegwire (Tm)
510(k) Number
FDA product code
LIT
FDA applicant
Boston Scientific Corp
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.

The device is a Catheter, Angioplasty, Peripheral, Transluminal, as defined by its device type and nomenclature. It is a guidewire used in peripheral transluminal angioplasty procedures.

It is supplied by Boston Scientific Corporation and has received FDA 510(k) clearance under K913391, classified as a Class II device with product code LIT. The device is intended for use in cardiovascular procedures and is not described as sterile, single-use, or reusable in the provided data.

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