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Surecath-ITP Percutaneous Access Kit

by Titan Medical, Inc.

510(k) K872149

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 NumberK872149 Date4 Aug 1987ClearedStatusActive

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  • Withdrawn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
LJT
Device Class
Class II
Regulation
21 CFR Part 880.5965
Advisory Committee
General Hospital
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 Surecath-ITP Percutaneous Access Kit is a subcutaneous, implanted port and catheter system designed for intravascular access. According to regulatory classification, it falls under the category of Port & Catheter, Implanted, Subcutaneous, Intravascular, and is intended for percutaneous insertion to facilitate long-term vascular access without suturing.

This kit is supplied as a sterile, single-use device and is regulated under FDA 510(k) clearance (K872149) with a product code of LJT. It is intended for use in general hospital settings and adheres to regulatory requirements outlined in 880.5965. The device is designed to secure catheters, tubes, or drains to a patient’s body without the need for sutures, ensuring stable access for intravenous, epidural, or drainage applications.

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