Cleared Special

K161208 - CROSSER CTO Recanalization Catheter

K161208 is an FDA 510(k) clearance for CROSSER CTO Recanalization Catheter, manufactured by Bard Peripheral Vacular, Inc.. The device is a Class 2 Cardiovascular device with product code PDU cleared through the Special 510(k) pathway after a 26-day FDA review.

K161208 · Bard Peripheral Vacular, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
26d
Days
Class 2
Risk

K161208 is an FDA 510(k) clearance for the CROSSER CTO Recanalization Catheter. Classified as Catheter For Crossing Total Occlusions (product code PDU), Class II - Special Controls.

Submitted by Bard Peripheral Vacular, Inc. (Tempe, US). The FDA issued a Cleared decision on May 24, 2016 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161208

510(k) Number K161208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2016
Decision Date May 24, 2016
Days to Decision 26 days
Submission Type Special
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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 57
Devices cleared under the same product code (PDU) and FDA review panel - the closest regulatory comparables to K161208.
XableCath Crossing Catheter
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K170349 · Ra Medical Systems,Inc · May 2017
Pioneer Plus Catheter
K162418 · Philips Volcano · Dec 2016
ELITECROSS Support Catheter
K150187 · Cordis Corporation, A Johnson & Johnson Company · May 2015
OUTBACK Elite Re-Entry Catheter
K150836 · Cordis Corporation, A Johnson & Johnson Co. · Apr 2015
MICRO GUIDE CATHETER ELITE
K140438 · Cordis Corp., A Johnson & Johnson Co. · Nov 2014