JETSTREAM G2 SYSTEM - Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter And Control Pod)

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

510(k) Number

K083837 ↗

FDA Product Code

MCW

Models / Variants

Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter And Control Pod)

PVCN100 (Pv Console)

Device Class

Class II

Regulation

21 CFR Part 870.4875

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Jetstream G3 (R) Sf 1.6 System

  Class II

  FDA 510(k) K111229 Active Cleared 1 Jun 2011

• Jetstream G3 L System Model PV31400 (Jetstream G3 L Catheter with Control Pod); PVCN100 (Pv Console)

  Class II

  FDA 510(k) K093918 Active Cleared 21 Jan 2010

• Jetstream G3 System, Model PV31300 ( Jetstream G3 Catheter and Control Pod)., PVCN100 (Pv Console)

  Class II

  FDA 510(k) K092332 Active Cleared 3 Sep 2009

• Jetstream G3 System, Model PV31300, Pv Console, Model PVCN100

  Class II

  FDA 510(k) K101221 Active Cleared 2 Jun 2010

• Modification to Pathway Pv Atherectomy System

  Class II

  FDA 510(k) K082186 Active Cleared 29 Aug 2008

• Jetstream Pathway Pv Atherectomy System, Model PV10300, PVCN100

  Class II

  FDA 510(k) K082664 Active Cleared 6 Oct 2008

See all devices from Pathway Medical Technologies, Inc. →

• What is the Jetstream G2 System designed for?

  The Jetstream G2 System is a catheter-based device designed for the removal of thrombus and atheromatous plaque from arteries. It mechanically breaks down and aspirates blockages.

• What components make up the Jetstream G2 System?

  The system consists of a sterile, single-use catheter with an electrically driven, differentially cutting tip and a reusable console that work together to remove arterial blockages.

• Is the Jetstream G2 System cleared by regulatory authorities?

  The Jetstream G2 System has FDA 510(k) clearance K083837 and is classified as Class II - Special Controls for Catheter, Peripheral, Atherectomy.

• How is the Jetstream G2 System supplied?

  The system is supplied as a sterile, single-use catheter with a reusable console. The catheter is not intended for reuse, while the console can be used multiple times.

• What is the regulatory classification of the Jetstream G2 System?

  The system is classified as Catheter, Peripheral, Atherectomy with product code MCW, Class II - Special Controls, and received FDA 510(k) clearance through the Cardiovascular advisory committee.