Cleared Special

JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 (K101221) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K101221 · Pathway Medical Technologies, Inc. · Cardiovascular device
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Jun 2010
Decision
30d
Days
Class 2
Risk

K101221 is an FDA 510(k) clearance for the JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL 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 June 2, 2010 after a review of 30 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

Submission Details

510(k) Number K101221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2010
Decision Date June 02, 2010
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K101221.
Auryon Atherectomy System
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K241553 · Eximo Medical, Ltd. · Jun 2024