Cleared Traditional

K101599 - RVT CTO DEVICE

K101599 is an FDA 510(k) clearance for RVT CTO DEVICE, manufactured by Revascular Therapeutics, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K101599 · Revascular Therapeutics, Inc. · Cardiovascular device
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Jan 2011
Decision
225d
Days
Class 2
Risk

K101599 is an FDA 510(k) clearance for the RVT CTO DEVICE. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Revascular Therapeutics, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 18, 2011 after a review of 225 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 Revascular Therapeutics, Inc. devices

FDA 510(k) Submission Details - K101599

510(k) Number K101599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2010
Decision Date January 18, 2011
Days to Decision 225 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 125d · This submission: 225d
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 43
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K101599.
WILDCAT CATHETER
K113838 · Avinger, Inc. · Mar 2012
CROSSER RECANALIZATION SYSTEM
K112308 · C.R. Bard, Inc. · Aug 2011
WILDCAT CATHETER
K111338 · Avinger, Inc. · Aug 2011
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