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Diamondback 360 Peripheral Orbital Atherectomy System

by Cardiovascular Systems Incorporated

510(k) K133399

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK133399 Date22 Nov 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2155-2014 FDA Class I initiated 23 May 2014

    CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.

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  • Withdrawn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
MCW
Device Class
Class II
Regulation
21 CFR Part 870.4875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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