Cleared Special

K151744 - Passeo-18 Peripheral Dilation Catheter

K151744 is the FDA 510(k) clearance for Passeo-18 Peripheral Dilation Catheter by Biotronik, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Special 510(k) pathway after a 101-day FDA review.

K151744 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
101d
Days
Class 2
Risk

K151744 is an FDA 510(k) clearance for the Passeo-18 Peripheral Dilation Catheter. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 8, 2015 after a review of 101 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biotronik, Inc. devices

Submission Details

510(k) Number K151744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2015
Decision Date October 08, 2015
Days to Decision 101 days
Submission Type Special
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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 191
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K151744.
Advocate PTA Catheter
K173621 · Merit Medical Systems, Inc. · Dec 2017
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
K170193 · Cook Incorporated · Feb 2017
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
K162350 · Boston Scientific Corporation · Nov 2016
Passeo-14 Peripheral Dilatation Catheter
K152240 · Biotronik, Inc. · Oct 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · Boston Scientific Corp · Jun 2015
Passeo-35 PTA Catheter
K142379 · Biotronik, Inc. · Dec 2014