Skip to content

Boston Scientific Ultra-Soft Sv Balloon Dilatation Catheter

by Boston Scientific Scimed, Inc.

510(k) K021735

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

23 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 NumberK021735 Date8 Aug 2002ClearedStatusActive

Recalls

23 recalls · FDA

  • 23 recalls, same reason

    • Terminated Z-1107-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1108-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1097-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1103-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1120-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1116-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1106-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1104-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1099-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1105-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1118-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1114-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1101-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1117-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1110-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1119-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1100-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1113-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1111-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1112-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1115-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1098-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735
    • Terminated Z-1096-03 FDA Unclassified (pre-2012) initiated 1 Jul 2003 on shared 510(k) K021735

    Some of the product pouches have holes in the seals.

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

Other devices from Boston Scientific Scimed, Inc.

See all devices from Boston Scientific Scimed, Inc. →