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Jetstream G2 System, Models PV20300 (Jetstream G2 Catheter and Control Pod); PVCN100 (PV Console)

by Pathway Medical Technologies, Inc. 2 variants

510(k) K083837

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK083837 Date13 Jan 2009ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MCW
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 870.4875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Jetstream G2 System is a catheter-based device designed for the removal of thrombus and atheromatous plaque from arteries. It consists of a catheter and a control pod that work together to mechanically break down and aspirate blockages.

The system comprises a sterile, single-use catheter with an electrically driven, differentially cutting tip and a reusable console. It is classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls, with FDA 510(k) clearance K083837.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.