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Groshong Cv Catheter Repair Kit

by Catheter Technology Corp.

510(k) K871998

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871998 Date24 Jun 1987ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1051-2023 FDA Class II initiated 4 Jan 2023

    Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

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  • Withdrawn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

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