Cleared Special

K122916 - JETSTREAM NAVITUS L SYSTEM JEYSTREAM NA...

K122916 is an FDA 510(k) clearance for JETSTREAM NAVITUS L SYSTEM JEYSTREAM NA..., manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Special 510(k) pathway after a 28-day FDA review.

K122916 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
28d
Days
Class 2
Risk

K122916 is an FDA 510(k) clearance for the JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JE.... 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 October 19, 2012 after a review of 28 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

FDA 510(k) Submission Details - K122916

510(k) Number K122916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2012
Decision Date October 19, 2012
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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. 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 K122916.
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 XC 2.4/3.4 SYSTEM
K130637 · Medrad, Inc. · Apr 2013
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
K121774 · Boston Scientific Corp · Sep 2012
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K111723 · Ev3, Inc. · Oct 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · Ev3, Inc. · Jan 2011