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Cardiovascular Procedure Kit 76515

by Terumo Cardiovascular Systems Corporation

Cardiovascular Procedure Kit 76515 is a cardioplegia solution administration kit (FDA Class II; FDA product code DTR, Heat-Exchanger, Cardiopulmonary Bypass) made by Terumo Cardiovascular Systems Corporation, cleared under FDA 510(k) K823451 on 14 Jan 1983 and listed in FDA GUDID since 11 Oct 2017 (UDI-DI 00699753506671), active as of 22 Oct 2026. 14 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

14 closed

Documents

510(k) K823451

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00699753506671 UDI-DI Date11 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK823451 Date14 Jan 1983DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K823451 decided 14 Jan 1983 Active
  • FDA GUDID UDI-DI 00699753506671 listed 11 Oct 2017 Listed

Recalls

14 recalls · FDA

    • Terminated Z-0158-2015 FDA Class II initiated 1 Mar 2011

    Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

  • 13 recalls, same reason

    • Terminated Z-2153-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2154-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2149-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2159-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2155-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2162-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2151-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2152-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2158-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2156-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2161-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2157-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010
    • Terminated Z-2160-2010 FDA Unclassified (pre-2012) initiated 8 Jun 2010

    Vent port may be occluded and prevent delivery of fluid

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-2162-2010
  2. Recall initiated FDA recalls Z-2151-2010
  3. Recall initiated FDA recalls Z-2152-2010
  4. Recall initiated FDA recalls Z-2158-2010
  5. Recall initiated FDA recalls Z-2156-2010
  6. Recall initiated FDA recalls Z-2161-2010
  7. Recall initiated FDA recalls Z-2157-2010
  8. Recall initiated FDA recalls Z-2160-2010
  9. Recall initiated FDA recalls Z-0158-2015
  10. Listed FDA GUDID 00699753506671

6 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

GUDID

Trade name
Cardiovascular Procedure Kit
Generic name
Cardioplegia solution administration kit
Model / reference
76515
Primary DI / UDI-DI
00699753506671
510(k) Number
FDA product code
DTR
GMDN term
Cardioplegia solution administration kit
Device class
Class II
Regulation number
870.4240
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardioplegia solution administration kit

Cleared under the same submission (K823451)

and 8 more cleared under K823451

Similar devices

Other devices filed under FDA product code DTR (Heat-Exchanger, Cardiopulmonary Bypass).

Other devices from Terumo Cardiovascular Systems Corporation

See all devices from Terumo Cardiovascular Systems Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)