Skip to content

Dorado PTA Balloon Dilatation Catheter

by Bard Peripheral Vascular, Inc.

510(k) K072283

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 NumberK072283 Date19 Sep 2007ClearedStatusActive

Recalls

15 recalls · FDA

  • 15 recalls, same reason

    • Terminated Z-2131-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2135-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2123-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2132-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2133-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2129-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2125-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2128-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2126-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2134-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2124-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2136-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2130-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2122-2010 FDA Unclassified (pre-2012) initiated 4 May 2010
    • Terminated Z-2127-2010 FDA Unclassified (pre-2012) initiated 4 May 2010

    The affected DORADO PTA Balloon Dilatation catheters contain catheter materials that, under certain conditions, are subject to premature breakage allowing the balloon to partially or completely separate from the catheter shaft.

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  • Withdrawn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
DQY
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Bard Peripheral Vascular, Inc.

See all devices from Bard Peripheral Vascular, Inc. →