Cleared Traditional

K081804 - PIONEER PLUS CATHETER

K081804 is an FDA 510(k) clearance for PIONEER PLUS CATHETER, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K081804 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
40d
Days
Class 2
Risk

K081804 is an FDA 510(k) clearance for the PIONEER PLUS CATHETER. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Medtronic, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on August 5, 2008 after a review of 40 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.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K081804

510(k) Number K081804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2008
Decision Date August 05, 2008
Days to Decision 40 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
85d faster than avg
Panel avg: 125d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDU Device Classification - Class 2, Special Controls

Product Code PDU Catheter For Crossing Total Occlusions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
Definition To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement.
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 - PDU Catheter For Crossing Total Occlusions

All 48
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K081804.
POWERWIRE RADIOFREQUENCY GUIDEWIRE
K101615 · Baylis Medical Co., Inc. · Jul 2010
PIONEER PLUS CATHETER, MODEL PLUS 120
K101777 · Medtronic Vascular · Jul 2010
MICRO GUIDE CATHETER XP
K082143 · Cordis Corp. · Aug 2008
PIONEER CATHETER
K072155 · Medtronic, Inc. · Oct 2007
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
K071227 · Spectranetics Corp. · Jul 2007
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
K071226 · Spectranetics Corp. · Jun 2007