Cleared Traditional

K071226 - 8FR TURBO BOOSTER

K071226 is an FDA 510(k) clearance for 8FR TURBO BOOSTER, manufactured by Spectranetics Corp.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K071226 · Spectranetics Corp. · Cardiovascular device
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Jun 2007
Decision
57d
Days
Class 2
Risk

K071226 is an FDA 510(k) clearance for the 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Spectranetics Corp. (Colorado Springs, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 57 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 Spectranetics Corp. devices

FDA 510(k) Submission Details - K071226

510(k) Number K071226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date June 29, 2007
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 39
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K071226.
PIONEER PLUS CATHETER
K081804 · Medtronic, Inc. · 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
CLIRPATH TURBO PERIPHERAL CATHETERS
K060012 · Spectranetics Corp. · Sep 2006
RF TUNNELER WIRE
K051670 · Baylis Medical Co., Inc. · Mar 2006
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
K052514 · Spectranetics Corp. · Oct 2005