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Vascucare Percutaneous Angioscopy Delivery System

by Vascucare, Inc.

510(k) K890047

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890047 Date20 Jun 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
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 Vascucare Percutaneous Angioscopy Delivery System is an angioscope classified under medical specialty Gastroenterology and Urology. It is a device designed for percutaneous use in vascular access procedures.

The device is supplied as a reusable system and has received FDA 510(k) clearance (K890047) with a decision of substantially equivalent. It is intended for use in facilitating the delivery of fluids and medications in patients with small blood vessels, including neonates, where short-term or long-term peripheral access to the central venous system is needed without frequent needlesticks.

Other devices from Vascucare, 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 Vascucare Percutaneous Angioscopy Delivery System used for?

    It is designed for percutaneous use in vascular access procedures to facilitate the delivery of fluids and medications in patients with small blood vessels, including neonates, where short-term or long-term peripheral access to the central venous system is needed without frequent needlesticks.

  • Is the Vascucare Percutaneous Angioscopy Delivery System reusable or single-use?

    The device is supplied as a reusable system, meaning it can be cleaned and used multiple times following appropriate reprocessing procedures, as indicated in its FDA 510(k) clearance documentation.

  • What regulatory clearance does the Vascucare Percutaneous Angioscopy Delivery System have?

    It has received FDA 510(k) clearance (K890047) with a decision of substantially equivalent, classified under product code LYK and regulation number 876.1500, and is designated as a Class II device.