Cleared Traditional

K172315 - Straub Endovascular System

K172315 is the FDA 510(k) clearance for Straub Endovascular System by Straub Medical AG. It is a Class 2 Cardiovascular device (product code MCW) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K172315 · Straub Medical AG · Cardiovascular device
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Apr 2018
Decision
254d
Days
Class 2
Risk

K172315 is an FDA 510(k) clearance for the Straub Endovascular System. Classified as Catheter, Peripheral, Atherectomy (product code MCW), Class II - Special Controls.

Submitted by Straub Medical AG (Wangs, CH). The FDA issued a Cleared decision on April 12, 2018 after a review of 254 days - an extended review cycle.

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. Standard predicate reliance. 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 Straub Medical AG devices

Submission Details

510(k) Number K172315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2017
Decision Date April 12, 2018
Days to Decision 254 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
129d slower than avg
Panel avg: 125d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Namsa
Barbara Atzenhoefer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MCW Catheter, Peripheral, Atherectomy

All 47
Devices cleared under the same product code (MCW) and FDA review panel - the closest regulatory comparables to K172315.
B-Laser Atherectomy System
K181642 · Eximo Medical, Ltd. · Oct 2018
Pantheris System
K173862 · Avinger, Inc. · May 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
K180416 · Cardiovascular Systems, Inc. · Apr 2018
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · Spectranetics, Inc. · Apr 2018
HAWKONE DIRECTIONAL ATHERECTOMY SYSTEM
K141801 · Covidien, LLC · Oct 2014
JETSTREAM XC 2.4/3.4
K133023 · Medrad, Inc. · Aug 2014