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Tenderflow Periatric Arterial Cannula

by Terumo Cardiovascular Systems Corporation

510(k) K063618

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

24 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK063618 Date13 Mar 2007ClearedStatusActive

Official records

Recalls

24 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-0630-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0635-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0636-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0633-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0631-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0637-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0639-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0634-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0640-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0632-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0638-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008
    • Terminated Z-0641-2009 FDA Unclassified (pre-2012) initiated 16 Oct 2008

    The introducer or stylet is difficult to remove from the pediatric arterial cannula body, which may result in the need to remove the cannula and replace it.

  • 12 recalls, same reason

    • Terminated Z-0876-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0880-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0881-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0877-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0884-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0879-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0874-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0875-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0882-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0883-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0885-2007 FDA Unclassified (pre-2012) initiated 22 May 2007
    • Terminated Z-0878-2007 FDA Unclassified (pre-2012) initiated 22 May 2007

    The bond may fail and a leak or separation of the device occur at the distal end (where this device connects to the arterial line).

Timeline

25 dated events

  1. Recall initiated FDA recalls Z-0636-2009
  2. Recall initiated FDA recalls Z-0633-2009
  3. Recall initiated FDA recalls Z-0631-2009
  4. Recall initiated FDA recalls Z-0637-2009
  5. Recall initiated FDA recalls Z-0639-2009
  6. Recall initiated FDA recalls Z-0634-2009
  7. Recall initiated FDA recalls Z-0640-2009
  8. Recall initiated FDA recalls Z-0632-2009
  9. Recall initiated FDA recalls Z-0638-2009
  10. Recall initiated FDA recalls Z-0641-2009

15 earlier events are in the sections above.

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
DWF
FDA applicant
Terumo Cardiovascular Systems Corp.
Device class
Class II
Regulation
21 CFR Part 870.4210
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Tenderflow Periarterial Arterial Cannula is a single-stage, wire-reinforced, dip-molded PVC cannula used during cardiopulmonary bypass surgery. It facilitates the return of oxygenated blood from a heart/lung machine to the patient's ascending aorta. The device features a kink-resistant, beveled, tapered tip and a non-reinforced clamping site.

This device is classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls. It is intended for use in cardiopulmonary bypass procedures and is supplied as a single-use device. The device has received FDA 510(k) clearance (K063618) and is manufactured by Terumo Cardiovascular Systems Corporation.

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