Guarddog Occlusion System, Occlusion Guidewire, 300 Cm, Guarddog Occlusion System Occlusion Guidewire, 200 Cm

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031357 ↗

FDA Product Code

MJN

Device Class

Class II

Regulation

21 CFR Part 870.4450

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

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

  Class II

  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 GuardDOG Occlusion Guidewire used for?

  The GuardDOG Occlusion Guidewire is designed for temporary vascular occlusion in peripheral vasculature during interventional procedures. Its 0.014-inch diameter guidewire with a distal compliant elastomer balloon allows localized vessel occlusion, enabling controlled therapeutic or diagnostic interventions where precise isolation of blood flow is required.

• How is the GuardDOG Occlusion System supplied, and is it reusable?

  The GuardDOG Occlusion System is supplied as a reusable occlusion guidewire paired with a CO₂ inflation device. However, the guidewire itself is intended for single-use per procedure to ensure sterile handling and patient safety. The inflation device is designed for repeated use across multiple procedures.

• What lengths are available for the GuardDOG Occlusion Guidewire?

  The GuardDOG Occlusion Guidewire is available in two lengths: 200 cm and 300 cm. These lengths accommodate varying procedural needs in peripheral vasculature, ensuring flexibility for different anatomical requirements.

• Is the GuardDOG Occlusion Guidewire sterile, and how should it be stored?

  Yes, the GuardDOG Occlusion Guidewire is supplied sterile for single-use per procedure. It should be stored in a clean, dry environment, protected from physical damage and contamination. Follow manufacturer guidelines for proper packaging and storage conditions to maintain sterility and functionality.

• What regulatory pathway does the GuardDOG Occlusion System follow?

  The GuardDOG Occlusion System has received FDA 510(k) clearance (K031357) as a Class II medical device under product code MJN. This clearance confirms its substantial equivalence to a predicate device and compliance with regulatory standards for intravascular occlusion devices in the United States.