Cleared Special

K082664 - JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100

K082664 is an FDA 510(k) clearance for JETSTREAM PATHWAY PV ATHERECTOMY 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 24-day FDA review.

K082664 · Pathway Medical Technologies, Inc. · Cardiovascular device
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Oct 2008
Decision
24d
Days
Class 2
Risk

K082664 is an FDA 510(k) clearance for the JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100. 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 October 6, 2008 after a review of 24 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 - K082664

510(k) Number K082664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date October 06, 2008
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
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 K082664.
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MODIFICATION TO: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
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