Cleared Special

Lithoplasty Peripheral Balloon Dilatation Catheter (K163306) - FDA 510(k) Clearance

Also marketed or referenced as:
Lithoplasty Generator And Connector Cable Lithoplasty Connector Cable

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

K163306 · Shockwave Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
29d
Days
Class 2
Risk

K163306 is an FDA 510(k) clearance for the Lithoplasty Peripheral Balloon Dilatation Catheter. 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 December 22, 2016 after a review of 29 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K163306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date December 22, 2016
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PPN Percutaneous Catheter, Ultrasound

All 10
Devices cleared under the same product code (PPN) and FDA review panel - the closest regulatory comparables to K163306.
Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement)
K191840 · Shockwave Medical, Inc. · Aug 2019
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