Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040C

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

510(k) Number

K972610 ↗

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

  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 primary purpose of the AngioJet Rapid Thrombectomy Catheters 3030C and 3040C?

  The AngioJet Rapid Thrombectomy Catheters 3030C and 3040C are designed to mechanically fragment and remove thrombus (clots) within the vascular system. They operate by delivering high-pressure saline jets to disrupt clots while simultaneously aspirating the debris through a distal port, effectively clearing occlusive material from arteries and venous access grafts. This dual-action approach helps restore blood flow during interventional cardiology and vascular procedures.

• How are these catheters supplied and used in clinical settings?

  The AngioJet Rapid Thrombectomy Catheters are supplied as single-use devices, meaning each catheter is intended for one procedure only. They are advanced percutaneously over a guidewire to the target lesion, where they are paired with a dedicated pump system to generate the high-pressure saline jets required for clot fragmentation and aspiration. This setup ensures precise and controlled removal of thrombus during interventions.

• Are the AngioJet catheters sterile, and what considerations should be taken for storage?

  The AngioJet Rapid Thrombectomy Catheters are supplied in a sterile condition, ensuring safety for single-use procedures. Storage should follow manufacturer guidelines to maintain sterility and functionality. Typically, this involves keeping the catheters in their original packaging, away from direct sunlight, extreme temperatures, and moisture, until ready for use. Always verify the expiration date and storage instructions provided with the device.

• What are the key differences between the 3030C and 3040C models?

  The 3030C and 3040C models are part of the AngioJet Rapid Thrombectomy Catheter line, with distinctions likely tied to their specific catheter dimensions or intended use within different vascular contexts. While the exact technical specifications (e.g., diameter, length, or flow rates) are not detailed here, these models are designed to address varying clinical scenarios in interventional cardiology and vascular procedures. For precise selection, refer to the manufacturer’s technical documentation or consult with a medical professional.

• Can these catheters be reused, or are they intended for single-use only?

  The AngioJet Rapid Thrombectomy Catheters are explicitly designed for single-use only. Reusing these devices is not recommended due to potential risks of contamination, device degradation, or compromised performance. Single-use ensures patient safety and maintains the device’s efficacy for its intended purpose, adhering to best practices in medical device usage.