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Fetch 2 Aspiration Catheter Model 109400-001

by Medrad Interventional/Possis

510(k) K101354

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101354 Date21 Jan 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1342-2016 FDA Class I initiated 22 Mar 2016 on shared 510(k) K101354

    Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.

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  • Withdrawn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
QEZ
Device Class
Class II
Regulation
21 CFR Part 870.5150
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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