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

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

510(k) Number

K993564 ↗

FDA Product Code

MCW

Device Class

Class II

Regulation

21 CFR Part 870.4875

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

  Class II

  FDA 510(k) K070363 Active Cleared 11 May 2007

• 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

• Perma-Pass Vascular Graft, 6S Graft, Model 31453, 6T Graft, Model 31452

  Class II

  FDA 510(k) K984182 Active Cleared 1 Feb 1999

See all devices from Possis Medical, Inc. →

• What is the Angiojet X-Stream Thrombectomy Catheter used for?

  The Angiojet X-Stream Thrombectomy Catheter is designed to remove thrombus from blood vessels using high-velocity saline jets that create a vacuum to break up and remove clots. It is intended for venous thrombectomy procedures and for breaking apart and removing thrombus from A-V access conduits when used with the AngioJet System.

• Is the Angiojet X-Stream Thrombectomy Catheter single-use or reusable?

  The Angiojet X-Stream Thrombectomy Catheter is supplied as a single-use device only. It is not designed for reuse and should be discarded after a single procedure to ensure patient safety and device performance.

• What is the regulatory classification of the Angiojet X-Stream Thrombectomy Catheter?

  The Angiojet X-Stream Thrombectomy Catheter is regulated as a Class II medical device under FDA 510(k) clearance K993564. It has the product code MCW and is classified under regulation number 870.4875 for cardiovascular applications.

• What manufacturer produces the Angiojet X-Stream Thrombectomy Catheter?

  The Angiojet X-Stream Thrombectomy Catheter is manufactured by Possis Medical, Inc., located at 9055 Evergreen Blvd. NW, Minneapolis, MN 55433. The company is responsible for the production and quality control of this medical device.