Skip to content

Interpret Catheter Linear Translator

by Intertherapy, Inc.

510(k) K913763

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913763 Date20 Nov 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
Interpret(Tm) Catheter Linear Translator
510(k) Number
FDA Product Code
LYK
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Interpret Catheter Linear Translator is a medical device classified as an Angioscope (FDA product code LYK), designed for intravascular imaging. It translates linear motion to facilitate the insertion and manipulation of catheters within blood vessels, enabling visualisation of vascular structures during procedures. This device supports diagnostic and interventional applications in gastroenterology and urology, where precise catheter navigation is critical.

The device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings such as radiology or catheterisation labs. It is not sterile at time of shipment but may be sterilised for reuse as per manufacturer guidelines. The Interpret Catheter Linear Translator holds FDA 510(k) clearance (K913763) under the Substantially Equivalent determination, with a classification of Class II. Compliance with FDA regulation 876.1500 ensures its adherence to safety and performance standards for intravascular imaging devices.

Other devices from Intertherapy, Inc.

Questions

AI-generated answers, 1 Oct 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 Interpret Catheter Linear Translator used for?

    The Interpret Catheter Linear Translator is designed for intravascular imaging, specifically to translate linear motion and facilitate the insertion and manipulation of catheters within blood vessels. This enables clear visualization of vascular structures during diagnostic and interventional procedures in gastroenterology and urology, where precise catheter navigation is essential.

  • Is the Interpret Catheter Linear Translator supplied sterile?

    No, the device is not sterile at the time of shipment. It is intended for reuse in controlled clinical settings like radiology or catheterization labs and must be sterilized according to the manufacturer’s guidelines before use.

  • What regulatory clearance does the Interpret Catheter Linear Translator hold?

    The device holds FDA 510(k) clearance (K913763) under a Substantially Equivalent determination, classified as Class II. It complies with FDA regulation 876.1500, ensuring adherence to safety and performance standards for intravascular imaging devices.

  • How is the Interpret Catheter Linear Translator supplied?

    The device is supplied as a reusable medical instrument. It is not sterile upon receipt and requires sterilization before reuse, following the manufacturer’s established protocols for clinical settings.

  • In which medical specialties is this device primarily used?

    The Interpret Catheter Linear Translator is primarily used in gastroenterology and urology. Its design supports precise catheter navigation during procedures in these specialties, where visualization of vascular structures is critical.