Cleared Special

K130637 - JETSTREAM XC 2.4/3.4 SYSTEM (FDA 510(k) Clearance)

Also includes:
JETSTREAM XC 2.1/3.0 SYSTEM JETSTREAM SC 1.85 SYSTEM JETSTREAM SC 1.6 SYSTEM

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

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
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 K130637.
Auryon Atherectomy System
K260244 · Eximo Medical · Apr 2026
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)
K250723 · Cardio Flow Inc., · Apr 2025
Turbo-Elite Laser Atherectomy Catheter
K250385 · Spectranetics · Mar 2025
Rotarex Atherectomy System
K242757 · Bard Peripheral Vascular, Inc. · Jan 2025
FreedomFlow™ Orbital Circumferential Atherectomy System
K242947 · Cardio Flow Inc., · Nov 2024
Auryon Atherectomy Catheter 1.7mm
K241553 · Eximo Medical, Ltd. · Jun 2024