Cleared Traditional

K133023 - JETSTREAM XC 2.4/3.4

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

K133023 is an FDA 510(k) clearance for JETSTREAM XC 2.4/3.4, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code MCW cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K133023 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
335d
Days
Class 2
Risk

K133023 is an FDA 510(k) clearance for the JETSTREAM XC 2.4/3.4. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Medrad, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 27, 2014 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medrad, Inc. devices

FDA 510(k) Submission Details - K133023

510(k) Number K133023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date August 27, 2014
Days to Decision 335 days
Submission Type Traditional
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
210d slower than avg
Panel avg: 125d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 132
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K133023.
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K143328 · Volcano Atheromed, Inc. · Dec 2014
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K141801 · Covidien, LLC · Oct 2014
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K140944 · Atheromed, Inc. · Aug 2014
TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM
K140775 · Spectranetics Corporation · Jul 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · Cardiovascular Systems, Inc. · Feb 2014