Cleared Special

K083837 - JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD)

Also marketed or referenced as:
PVCN100 (PV CONSOLE)

K083837 is an FDA 510(k) clearance for JETSTREAM G2 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 21-day FDA review.

K083837 · Pathway Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
21d
Days
Class 2
Risk

K083837 is an FDA 510(k) clearance for the JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD). 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 January 13, 2009 after a review of 21 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 - K083837

510(k) Number K083837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2008
Decision Date January 13, 2009
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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
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K082664 · Pathway Medical Technologies, Inc. · Oct 2008
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K082186 · Pathway Medical Technologies, Inc. · Aug 2008