Cleared Traditional

K161384 - Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable

K161384 is an FDA 510(k) clearance for Lithoplasty Peripheral Balloon Dilatati..., manufactured by Shockwave Medical, Inc.. The device is a Class 2 Cardiovascular device with product code PPN cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K161384 · Shockwave Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
118d
Days
Class 2
Risk

K161384 is an FDA 510(k) clearance for the Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and.... Classified as Percutaneous Catheter, Ultrasound (product code PPN), Class II - Special Controls.

Submitted by Shockwave Medical, Inc. (Fremont, US). The FDA issued a Cleared decision on September 14, 2016 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Shockwave Medical, Inc. devices

FDA 510(k) Submission Details - K161384

510(k) Number K161384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2016
Decision Date September 14, 2016
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

PPN Device Classification - Class 2, Special Controls

Product Code PPN Percutaneous Catheter, Ultrasound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature.
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
NCT02369848 Completed Interventional Industry-sponsored

Shockwave Lithoplasty DISRUPT Trial for PAD (DISRUPT PAD 2)

60
Patients (actual)
8
Sites
Treatment
Purpose
Open label
Masking
Condition studied Peripheral Arterial Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Thomas Zeller, MD
Sponsor Shockwave Medical, Inc. (industry)
Started 2015-06-01 → Primary completion 2015-12-01 → Completed 2016-12-01
Primary outcome
Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis
Secondary outcome
Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)
View full study on ClinicalTrials.gov

Regulatory Peers - PPN Percutaneous Catheter, Ultrasound

All 13
Devices cleared under the same product code (PPN) and FDA review panel - the closest regulatory comparables to K161384.
Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable
K180958 · Shockwave Medical, Inc. · Jul 2018
Shockwave Medical Intravascular Lithotripsy (IVL) System
K180454 · Shockwave Medical, Inc. · Jun 2018
Lithoplasty Peripheral Balloon Dilatation Catheter
K163306 · Shockwave Medical, Inc. · Dec 2016