Angiojet Ultra Spiroflex Vg Thrombectomy Set, Model 106608

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K080806 ↗

FDA Product Code

QEZ

Device Class

Class II

Regulation

21 CFR Part 870.5150

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Guarddog Occlusion System

  Class II

  FDA 510(k) K062220 Active Cleared 11 Aug 2006

• Fetch Aspiration Catheter

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  FDA 510(k) K070363 Active Cleared 11 May 2007

• Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002

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  FDA 510(k) K993564 Active Cleared 28 Apr 2000

• Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039

  Class II

  FDA 510(k) K071342 Active Cleared 31 Jul 2007

• Angiojet Ultra Dvx Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001

  Class II

  FDA 510(k) K090253 Active Cleared 8 Apr 2009

• Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit

  Class II

  FDA 510(k) K040013 Active Cleared 18 May 2004

See all devices from Possis Medical, Inc. →

• What is the Angiojet Ultra Spiroflex Vg Thrombectomy Set, Model 106608 used for?

  It is intended for use with the Angiojet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries greater than 3 mm in diameter, enabling mechanical thrombectomy in peripheral vascular interventions.

• Is the Angiojet Ultra Spiroflex Vg Thrombectomy Set, Model 106608 sterile and single-use?

  Yes, the device is supplied sterile and is designed as a single-use, disposable unit, meaning it should not be reprocessed or reused after a procedure to maintain sterility and performance integrity.

• What components are included in the Angiojet Ultra Spiroflex Vg Thrombectomy Set, Model 106608?

  The set consists of a thrombectomy catheter and an integrated pump combined into one unit, designed to work exclusively with the Angiojet Ultra Console for aspiration-based thrombus removal.

• What regulatory pathway was used for the Angiojet Ultra Spiroflex Vg Thrombectomy Set, Model 106608?

  The device was cleared through the FDA’s traditional 510(k) process under clearance number K080806, classified as a Class 2 medical device with product code QEZ and regulation number 870.5150.