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Nova Balloon Thermodilution Infusion

by Nova Medical Specialties 2 variants

510(k) K832287

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

21 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 NumberK832287 Date19 Oct 1983ClearedStatusActive

Recalls

21 recalls · FDA

    • Terminated Z-1116-2007 FDA Unclassified (pre-2012) initiated 5 Jun 2007

    Cracks at the Catheter Tip

  • 20 recalls, same reason

    • Terminated Z-0995-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1002-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1001-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1014-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-0996-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1003-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1000-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1013-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1009-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1010-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1012-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1004-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1011-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1007-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-0998-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-0997-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1005-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1008-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-0999-05 FDA Unclassified (pre-2012) initiated 25 May 2005
    • Terminated Z-1006-05 FDA Unclassified (pre-2012) initiated 25 May 2005

    Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.

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
DYG
Device Class
Class II
Regulation
21 CFR Part 870.1240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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