Skip to content

Atlantis 018 Peripheral Imaging Catheter

by Boston Scientific

510(k) K073623

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 NumberK073623 Date13 Mar 2008ClearedStatusActive

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  • Withdrawn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
ITX
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 892.1570
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 Atlantis 018 Peripheral Imaging Catheter is a 40MHz ultrasonic imaging catheter designed for intravascular ultrasound examination of peripheral vessels. The device comprises an imaging core with a rotating drive cable and a distal transducer, along with a catheter body featuring a telescoping section for 15 cm of linear movement.

This sterile, single-use device is designed to be operated with compatible Boston Scientific Corporation imaging systems, including the Galaxy2, Galaxy, and iLab Imaging System. It connects to the Boston Scientific IVUS System Motor for operation. The device has received FDA 510(k) clearance.

Other devices from Boston Scientific

See all devices from Boston Scientific →