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Platinum Plus Guidewire with Hydrophilic Coating

by Boston Scientific

510(k) K945379

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK945379 Date5 Jun 1995ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0030-2009 FDA Unclassified (pre-2012) initiated 25 Aug 2008

    Boston Scientific is initiating a voluntary recall of the Platinum Plus Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to

    • Terminated Z-0031-2009 FDA Unclassified (pre-2012) initiated 25 Aug 2008

    Boston Scientific is initiating a voluntary recall of the Platinum Plus" Guidewire (peripheral). BSC has received reports that product may be labeled as a 260 CM long guidewire when the actual packaged device is a 180 CM long guidewire and the product may be labeled as a 180 CM long guidewire when the actual packaged device is a 260 CM long guidewire. There is no expected potential for injury to

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  • Withdrawn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
DQX
FDA applicant
Boston Scientific Corp
Device Class
Class II
Regulation
21 CFR Part 870.1330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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