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Trans-Catheter Extractor

by Tran Pa-C, Inc.

510(k) K063048

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK063048 Date14 Sep 2007ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2559-2024 FDA Class II initiated 11 Jun 2024

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

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  • Withdrawn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
ODY
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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 Trans-Catheter Extractor is a mechanical catheter accessory device designed for the minimally invasive removal of tunneled long-term catheters. It is specifically indicated for use with tunneled, double lumen Permcath catheters ranging from 10.8F to 14.5F in size.

This device is intended for use by clinicians within a clinical setting. It is regulated under FDA 510(k) clearance, identified by K-number K063048, and falls under regulation number 880.5970.

Questions

AI-generated answers, 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.

  • What is the intended use of the Trans-Catheter Extractor?

    This device is a mechanical accessory specifically designed for the minimally invasive removal of tunneled long-term catheters. It is intended for use by clinicians within a clinical setting.

  • Which catheter sizes are compatible with this extractor?

    The Trans-Catheter Extractor is indicated for use with tunneled, double lumen Permcath catheters that range in size from 10.8F to 14.5F.

  • What is the regulatory status of this device?

    The Trans-Catheter Extractor is regulated under FDA 510(k) clearance, identified by K-number K063048. It is classified under regulation number 880.5970.