Cleared Special

K101334 - JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD)

Also marketed or referenced as:
PVCN100 (PV CON

K101334 is an FDA 510(k) clearance for JETSTREAM G3 SE 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 30-day FDA review.

K101334 · Pathway Medical Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
30d
Days
Class 2
Risk

K101334 is an FDA 510(k) clearance for the JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE.... 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 11, 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

FDA 510(k) Submission Details - K101334

510(k) Number K101334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date June 11, 2010
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K101334.
JETSTREAM NAVITUS SYSTEM
K110626 · Pathway Medical Technologies, Inc. · Apr 2011
STEALTH 360 ORBITAL PAD SYSTEM
K110389 · Cardiovascular Systems, Inc. · Mar 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · Ev3, Inc. · Jan 2011
JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
K101221 · Pathway Medical Technologies, Inc. · Jun 2010
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