Cleared Special

K091509 - JETSTREAM G2 NXT SYSTEM, MODEL PV20300

K091509 is an FDA 510(k) clearance for JETSTREAM G2 NXT 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 28-day FDA review.

K091509 · Pathway Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
28d
Days
Class 2
Risk

K091509 is an FDA 510(k) clearance for the JETSTREAM G2 NXT SYSTEM, MODEL PV20300. 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 June 19, 2009 after a review of 28 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.

FDA 510(k) Submission Details - K091509

510(k) Number K091509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date June 19, 2009
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 145
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K091509.
JETSTREAM G3 SYSTEM
K093456 · Pathway Medical Technologies, Inc. · Dec 2009
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DIAMONDBACK 360 DBX
K090521 · Cardiovascular Systems, Inc. · Mar 2009
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD)
K090325 · Pathway Medical Technologies, Inc. · Mar 2009
JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
K083489 · Pathway Medical Technologies, Inc. · Jan 2009
K091509 · JETSTREAM G2 NXT SYSTEM, MODEL PV20300
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