Cleared Special

K093456 - JETSTREAM G3 SYSTEM

K093456 is an FDA 510(k) clearance for JETSTREAM G3 SYSTEM, manufactured by Pathway Medical Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 26-day FDA review.

K093456 · Pathway Medical Technologies, Inc. · Cardiovascular device
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Dec 2009
Decision
26d
Days
Class 2
Risk

K093456 is an FDA 510(k) clearance for the JETSTREAM G3 SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Pathway Medical Technologies, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 1, 2009 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pathway Medical Technologies, Inc. devices

FDA 510(k) Submission Details - K093456

510(k) Number K093456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2009
Decision Date December 01, 2009
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

MCW Device Classification - Class 2, Special Controls

Product Code MCW Catheter, Peripheral, Atherectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 100
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K093456.
JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
K100462 · Pathway Medical Technologies, Inc. · May 2010
TURBO-TANDEM SYSTEM MODEL 472-110
K094036 · Spectranetics Corp. · Jan 2010
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD)
K093918 · Pathway Medical Technologies, Inc. · Jan 2010
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K093301 · Ev3, Inc. · Nov 2009
JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
K092332 · Pathway Medical Technologies, Inc. · Sep 2009
JETSTREAM G2 NXT SYSTEM, MODEL PV20300
K091509 · Pathway Medical Technologies, Inc. · Jun 2009