Cleared Special

K130637 - JETSTREAM XC 2.4/3.4 SYSTEM

Also marketed or referenced as:
JETSTREAM XC 2.1/3.0 SYSTEM JETSTREAM SC 1.85 SYSTEM JETSTREAM SC 1.6 SYSTEM

K130637 is the FDA 510(k) clearance for JETSTREAM XC 2.4/3.4 SYSTEM by Medrad, Inc.. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Special 510(k) pathway after a 30-day FDA review.

K130637 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
30d
Days
Class 2
Risk

K130637 is an FDA 510(k) clearance for the JETSTREAM XC 2.4/3.4 SYSTEM. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Medrad, Inc. (Kirkland, US). The FDA issued a Cleared decision on April 10, 2013 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 Medrad, Inc. devices

Submission Details

510(k) Number K130637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date April 10, 2013
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.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00676494 Completed Interventional Industry-sponsored

The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions

172
Patients (actual)
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Artery Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Thomas Zeller, MD
Sponsor Pathway Medical Technologies Inc. (industry)
Started 2006-02-01 → Primary completion 2007-07-01 → Completed 2008-02-01
Primary outcome
Major Adverse Events (MAEs) Within 30 Days
Secondary outcome
Average Rutherford Classification Score at 6 Months
View full study on ClinicalTrials.gov

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 54
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K130637.
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 2014
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
K133566 · Boston Scientific Corp · Dec 2013
JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
K122916 · Medrad, Inc. · Oct 2012
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · Boston Scientific Corp · Sep 2012
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K111723 · Ev3, Inc. · Oct 2011