Product Code: PDU FDA class 2 21 CFR 870.1250

Catheter For Crossing Total Occlusions

Cardiovascular

The Catheter for Crossing Total Occlusions is a cardiovascular device used to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions, including subchronic and chronic total occlusions in peripheral or coronary vessels. It falls under the Cardiovascular medical specialty and is classified as a Class 2 device under regulation 870.1250, requiring 510(k) premarket notification. These catheters are used in interventional cardiology and vascular procedures to enable revascularization of completely blocked arteries. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: PDU
Device Class: FDA class 2
Regulation Number: 870.1250
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252315	Santreva-ATK Endovascular Revasculariztion Catheter	Sep 22, 2025	Substantially Equivalent	AngioSafe, Inc.
K251158	PowerWire® 14 Radiofrequency Guidewire Kit	Sep 11, 2025	Unknown	Baylis Medical Technologies, Inc.
K251376	LimFlow ARC	May 31, 2025	Substantially Equivalent	LimFlow, Inc.
K232562	PowerWire Radiofrequency Guidewire Kit	Feb 28, 2024	Unknown	Baylis Medical Technologies, Inc.
K230159	SoundBite® Crossing System XS Peripheral	Aug 28, 2023	Substantially Equivalent	Soundbite Medical Solutions, Inc.
K230594	Tigereye ST CTO-Crossing Catheter	Apr 25, 2023	Substantially Equivalent	Avinger, Inc.
K221163	Tunnel Crossing Catheter	Jan 19, 2023	Substantially Equivalent	Tractus Vascular, LLC
K221541	LimFlow ARC	Aug 31, 2022	Substantially Equivalent	LimFlow, Inc.
K220544	DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)	Jun 29, 2022	Substantially Equivalent	Ra Medical Systems,Inc
K211802	GoBack Crossing Catheter	Mar 01, 2022	Substantially Equivalent	Upstream Peripheral Technologies, Ltd.
K212468	Tigereye CTO-Crossing Catheter	Jan 06, 2022	Substantially Equivalent	Avinger, Inc.
K203363	Crosser iQ CTO Recanalization System	Aug 12, 2021	Substantially Equivalent	C.R. Bard, Inc.
K210664	DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)	Jul 27, 2021	Substantially Equivalent	Ra Medical Systems,Inc
K210839	SoundBite Crossing System - Peripheral (14P)	Apr 20, 2021	Substantially Equivalent	Soundbite Medical Solutions, Inc.
K201330	Tigereye CTO-Crossing Catheter	Sep 10, 2020	Substantially Equivalent	Avinger, Inc.
K192211	SoundBite Console, SoundBite Active Wire 18	Jan 17, 2020	Substantially Equivalent	Soundbite Medical Solution, Inc.
K183357	XableCath Crossing Catheter	Jan 21, 2019	Substantially Equivalent	Xablecath, Inc.
K170349	RA-308 Excimer Laser System, Excimer Laser Catheter	May 24, 2017	Substantially Equivalent	Ra Medical Systems,Inc
K162418	Pioneer Plus Catheter	Dec 02, 2016	Substantially Equivalent	Philips Volcano
K161208	CROSSER CTO Recanalization Catheter	May 24, 2016	Substantially Equivalent	Bard Peripheral Vacular, Inc.
K150187	ELITECROSS Support Catheter	May 19, 2015	Substantially Equivalent	Cordis Corporation, A Johnson & Johnson Company
K150836	OUTBACK Elite Re-Entry Catheter	Apr 29, 2015	Substantially Equivalent	Cordis Corporation, A Johnson & Johnson Co.
K140438	MICRO GUIDE CATHETER ELITE	Nov 14, 2014	Substantially Equivalent	Cordis Corp., A Johnson & Johnson Co.
K140185	OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE	May 01, 2014	Substantially Equivalent	Avinger, Inc.
K140288	TRUEPATH CTO DEVICE	Apr 16, 2014	Substantially Equivalent	Boston Scientific Corp
K131914	OFFROAD RE-ENTRY CATHETER SYSTEM	Oct 31, 2013	Substantially Equivalent	Boston Scientific Corp
K123532	OCELOT PIXL CATHETER	Dec 14, 2012	Substantially Equivalent	Avinger, Inc.
K123462	OCELOT CATHETER	Dec 07, 2012	Substantially Equivalent	Avinger, Inc.
K122380	OCELOT SYSTEM	Nov 07, 2012	Substantially Equivalent	Avinger, Inc.
K120533	BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES	May 22, 2012	Substantially Equivalent	Bridgepoint Medical
K120273	KITTYCAT CATHETER, KITTYCAT 2 CATHETER	Mar 30, 2012	Substantially Equivalent	Avinger, Inc.
K113838	WILDCAT CATHETER	Mar 12, 2012	Substantially Equivalent	Avinger, Inc.
K112308	CROSSER RECANALIZATION SYSTEM	Aug 17, 2011	Substantially Equivalent	C.R. Bard, Inc.
K111338	WILDCAT CATHETER	Aug 11, 2011	Substantially Equivalent	Avinger, Inc.
K101599	RVT CTO DEVICE	Jan 18, 2011	Substantially Equivalent	Revascular Therapeutics, Inc.
K101615	POWERWIRE RADIOFREQUENCY GUIDEWIRE	Jul 28, 2010	Substantially Equivalent	Baylis Medical Co., Inc.
K101777	PIONEER PLUS CATHETER, MODEL PLUS 120	Jul 23, 2010	Substantially Equivalent	Medtronic Vascular
K092175	THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200	Feb 17, 2010	Substantially Equivalent	Flowcardia, Inc.
K091119	MODIFICATION TO THE CROSSER SYSTEM	May 15, 2009	Substantially Equivalent	Flowcardia, Inc.
K083814	OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120	Jan 13, 2009	Substantially Equivalent	Cordis Corp., A Johnson & Johnson Co.
K082143	MICRO GUIDE CATHETER XP	Aug 25, 2008	Substantially Equivalent	Cordis Corp.
K081804	PIONEER PLUS CATHETER	Aug 05, 2008	Substantially Equivalent	Medtronic, Inc.
K072776	THE CROSSER SYSTEM	Dec 07, 2007	Substantially Equivalent	Flowcardia, Inc.
K072155	PIONEER CATHETER	Oct 05, 2007	Substantially Equivalent	Medtronic, Inc.
K071227	CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15	Jul 11, 2007	Substantially Equivalent	Spectranetics Corp.
K071226	8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043	Jun 29, 2007	Substantially Equivalent	Spectranetics Corp.
K060012	CLIRPATH TURBO PERIPHERAL CATHETERS	Sep 29, 2006	Substantially Equivalent	Spectranetics Corp.
K051670	RF TUNNELER WIRE	Mar 30, 2006	Substantially Equivalent	Baylis Medical Co., Inc.
K052514	CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001	Oct 19, 2005	Substantially Equivalent	Spectranetics Corp.
K052296	CLIRPATH TURBO EXCIMER LASER CATHETERS	Sep 02, 2005	Substantially Equivalent	Spectranetics Corp.
K043465	2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011	Aug 18, 2005	Substantially Equivalent	Spectranetics Corp.
K050916	SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]	Jun 08, 2005	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K040067	CLIRPATH EXCIMER LASER CATHETER	Apr 27, 2004	Substantially Equivalent	Spectranetics Corp.
K033535	LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES	Jan 07, 2004	Substantially Equivalent	Lumend, Inc.
K031842	SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM	Nov 21, 2003	Substantially Equivalent	Intra Luminal Therapeutics, Inc.
K031005	LUMEND FRONTRUNNER GW CTO CATHETER	Jun 18, 2003	Substantially Equivalent	Lumend, Inc.
K023114	LUMEND FRONTRUNNER CTO CATHETER	Jan 23, 2003	Substantially Equivalent	Lumend, Inc.