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JETSTREAM G3 L SYSTEM, PV CONSOLE - PV31300

by Pathway Medical Technologies, Inc.

510(k) K100462

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 · Traditional NumberK100462 Date19 May 2010ClearedStatusActive

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  • Withdrawn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
PV31300
Device Class
Class II
Regulation
21 CFR Part 870.4875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 G3 L System is a peripheral atherectomy device designed for debulking and thrombus removal, consisting of a sterile, single-use catheter with an electrically-driven, differentially cutting tip and a reusable PV console. It is classified as a Catheter, Peripheral, Atherectomy device.

The system is supplied with models Pv31400, Pv31300, and Pvcn100, and is intended for use in treating peripheral vascular disease. The device has been cleared by the FDA under the 510(k) clearance process, with a regulation number of 870.4875, and is classified as a Class II device with special controls.

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Questions

AI-generated answers, 26 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 G3 L System used for?

    The Jetstream G3 L System is used for debulking and thrombus removal in treating peripheral vascular disease.

  • Is the Jetstream G3 L System supplied sterile?

    Yes, the system is supplied with a sterile, single-use catheter.

  • What models are available for the Jetstream G3 L System?

    The system is supplied with models Pv31400, Pv31300, and Pvcn100.

  • Is the PV console reusable?

    Yes, the PV console is reusable, while the catheter is single-use.