Cleared Traditional

K152240 - Passeo-14 Peripheral Dilatation Catheter

K152240 is an FDA 510(k) clearance for Passeo-14 Peripheral Dilatation Catheter, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K152240 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
59d
Days
Class 2
Risk

K152240 is an FDA 510(k) clearance for the Passeo-14 Peripheral Dilatation 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 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K152240

510(k) Number K152240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2015
Decision Date October 08, 2015
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 382
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K152240.
Cronus HP - High Pressure Peripheral Balloon Catheter
K151141 · Nipro Medical Corporation · Jan 2016
PolarCath Peripheral Dilatation System
K152665 · Nucyro Vascular, LLC · Oct 2015
Passeo-18 Peripheral Dilation Catheter
K151744 · Biotronik, Inc. · Oct 2015
Metacross OTW PTA Balloon Dilatation Catheter
K152080 · KANEKA Corporation · Sep 2015
Chameleon PTA Balloon Catheter
K151678 · Av Medical Technologies, Ltd. · Sep 2015
Ebony PTA .014 RX Pheripheral Dilatation Catheter
K152230 · Natec Medical · Sep 2015
K152240 · Passeo-14 Peripheral Dilatation Catheter
Download PDF FDA Summary Biotronik, Inc.