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Extroducer Infusion Catheter System

by SmartWise Sweden AB 2 variants

510(k) K213442

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 NumberK213442 Date10 Jun 2022ClearedStatusActive

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  • Withdrawn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
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
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 Extroducer Infusion Catheter System is a continuous flush catheter device classified under regulation number 870.1210 and product code KRA. It is a Class II medical device intended for cardiovascular applications as indicated by the advisory committee description.

The device received FDA 510(k) clearance under K-number K213442 on June 10, 2022, following a traditional review process. It is manufactured by SmartWise Sweden AB and is supplied as a single-use device for infusion procedures in clinical settings, with no MRI safety information or reusability claims provided in the data.

Other devices from SmartWise Sweden AB

Questions

AI-generated answers, 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.

  • What is the Extroducer Infusion Catheter System used for?

    The Extroducer Infusion Catheter System is a Class II medical device designed for cardiovascular applications. It is a continuous flush catheter used for infusion procedures in clinical settings, as indicated by its advisory committee classification.

  • Is the Extroducer Infusion Catheter System reusable or single-use?

    The Extroducer Infusion Catheter System is supplied as a single-use device for infusion procedures in clinical settings. The device is not intended for reuse, and no reusability claims are provided in the available data.

  • What regulatory approvals does the Extroducer Infusion Catheter System have?

    The Extroducer Infusion Catheter System received FDA 510(k) clearance under K-number K213442 on June 10, 2022, following a traditional review process. It is classified under regulation number 870.1210 and product code KRA.

  • Who manufactures the Extroducer Infusion Catheter System?

    The Extroducer Infusion Catheter System is manufactured by SmartWise Sweden AB, located at Alfred Nobels Allé 150, Tullinge, SE-146 48. The company received FDA clearance for this device through their traditional review submission.