Cleared Traditional

K141322 - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

K141322 is an FDA 510(k) clearance for ADVANCE ENFORCER 35 FOCAL FORCE PTA BAL..., manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code PNO cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K141322 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
311d
Days
Class 2
Risk

K141322 is an FDA 510(k) clearance for the ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER. Classified as Catheter, Percutaneous, Cutting/scoring (product code PNO), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 27, 2015 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K141322

510(k) Number K141322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2014
Decision Date March 27, 2015
Days to Decision 311 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
186d slower than avg
Panel avg: 125d · This submission: 311d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PNO Device Classification - Class 2, Special Controls

Product Code PNO Catheter, Percutaneous, Cutting/scoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
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 - PNO Catheter, Percutaneous, Cutting/scoring

All 45
Devices cleared under the same product code (PNO) and FDA review panel - the closest regulatory comparables to K141322.
FLEX SCORING CATHETER
K152789 · Venturemed Group · May 2016
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253 · Boston Scientific Limited · Jun 2015
AngioSculpt PTA Scoring Baloon Catheters
K150634 · Spectranetrics · Apr 2015
AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
K142983 · Angioscore, Inc. · Mar 2015
ANGIOSCULPT PTA SCORING BALLOON WITH HYDROCROSS CAOTING
K133998 · Angioscore, Inc. · Apr 2014
ANGIOSCULPT PTA SCORING BALLOON CATHETER
K122685 · Angioscore, Inc. · Jan 2013
K141322 · ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
Download PDF FDA Summary Cook Incorporated