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Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600, CC5500. CC2400PC, CC2800PC, CC3200PC(32 Cm), CC3200PC(36 Cm)

by Diatek, Inc.

510(k) K010399

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK010399 Date14 Aug 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2242-2008 FDA Unclassified (pre-2012) initiated 10 Jun 2008

    The tips may not have been adequately welded to the catheter body.

    • Terminated Z-0084-04 FDA Unclassified (pre-2012) initiated 16 Sep 2003 on shared 510(k) K010399

    wrong product in box

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
MSD
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Diatek Cannon-Cath is an implanted hemodialysis catheter. It is designed to provide vascular access for hemodialysis procedures.

This device is authorized under FDA 510(k) number K010399. It is available in multiple model configurations, including CC2400, CC2800, CC3200, CC3600, CC5500, CC2400PC, CC2800PC, and specific lengths for the CC3200PC model.

Other devices from Diatek, Inc.

See all devices from Diatek, Inc. →

Questions

AI-generated answers, 25 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 primary purpose of the Diatek Cannon-Cath?

    The Diatek Cannon-Cath is an implanted hemodialysis catheter designed specifically to provide vascular access for patients undergoing hemodialysis procedures.

  • Which model configurations are available for this catheter?

    The device is available in several configurations, including models CC2400, CC2800, CC3200, CC3600, and CC5500. Additionally, it is offered in PC variants, such as CC2400PC, CC2800PC, and specific length options for the CC3200PC model.

  • What is the regulatory status of the Diatek Cannon-Cath?

    This device is authorized under FDA 510(k) number K010399. The submission was processed as a traditional 510(k) and determined to be substantially equivalent to existing devices.