Cleared Traditional

K043465 - 2.5 MM TURBO CLIRPATH EXCIMER LASER CAT...

K043465 is an FDA 510(k) clearance for 2.5 MM TURBO CLIRPATH EXCIMER LASER CAT..., 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 246-day FDA review.

K043465 · Spectranetics Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
246d
Days
Class 2
Risk

K043465 is an FDA 510(k) clearance for the 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011. 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 August 18, 2005 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Spectranetics Corp. devices

FDA 510(k) Submission Details - K043465

510(k) Number K043465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date August 18, 2005
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
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 K043465.
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
CLIRPATH TURBO EXCIMER LASER CATHETERS
K052296 · Spectranetics Corp. · Sep 2005
CLIRPATH EXCIMER LASER CATHETER
K040067 · Spectranetics Corp. · Apr 2004