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OptiCross 18 Peripheral Imaging Catheter

by Boston Scientific

510(k) K222568

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222568↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK222568 Date23 Sep 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
OBJ
FDA applicant
Boston Scientific Corporation
Device class
Class II
Regulation
21 CFR Part 870.1200
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 OptiCross 18 Peripheral Imaging Catheter is an intravascular ultrasound catheter designed for imaging peripheral blood vessels. It combines real-time ultrasound imaging with catheter-based navigation to visualize arterial structures, aiding in diagnostic and interventional procedures such as peripheral artery disease assessment or endovascular interventions.

This device is intended for single-use and is supplied sterile. It is classified as a Class II medical device under FDA regulations (870.1200) and has received FDA 510(k) clearance as substantially equivalent. The catheter is compatible with MRI environments, as indicated by its regulatory filings, and is available in a specific 18 French size. Storage and handling must adhere to sterile medical device protocols.

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Questions

AI-generated answers, 18 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 primary use case for the OptiCross 18 Peripheral Imaging Catheter in clinical practice?

    The OptiCross 18 Peripheral Imaging Catheter is designed for intravascular ultrasound imaging of peripheral blood vessels. It combines real-time ultrasound with catheter-based navigation to help visualize arterial structures, which aids in diagnosing peripheral artery disease and guiding endovascular interventions like stent placement or angioplasty.

  • Is the OptiCross 18 Peripheral Imaging Catheter reusable, or is it intended for single-use only?

    The device is explicitly intended for single-use, as stated in its description. This aligns with standard sterile medical device protocols to ensure patient safety and prevent cross-contamination.

  • What size is the OptiCross 18 Peripheral Imaging Catheter, and does it come in multiple sizes?

    The OptiCross 18 Peripheral Imaging Catheter is available in a single size, specifically 18 French. The product code and regulatory filings do not indicate alternative sizes, so this is the only version currently offered.

  • Can this catheter be used in an MRI environment, and if so, what does that mean for compatibility?

    Yes, the OptiCross 18 Peripheral Imaging Catheter is compatible with MRI environments, as noted in its regulatory filings. This means it can be used in procedures involving magnetic resonance imaging without interference, though standard MRI safety protocols (e.g., non-ferromagnetic materials) should still be followed.

  • How should the OptiCross 18 Peripheral Imaging Catheter be stored to maintain sterility and functionality?

    Since the device is supplied sterile, it must be stored according to sterile medical device protocols—typically in its original packaging, away from direct sunlight, extreme temperatures, and contamination. Check the packaging for specific storage instructions, such as refrigeration or room-temperature conditions, to preserve sterility and performance.