Product Code: DRA FDA class 2 21 CFR 870.1280

Catheter, Steerable

Cardiovascular

The Steerable Catheter is a cardiovascular device with a deflectable tip that can be actively directed by the operator to navigate complex vascular anatomy during diagnostic or interventional procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRA and it is regulated under 21 CFR 870.1280 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DRA
Device Class: FDA class 2
Regulation Number: 870.1280
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 41 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250529	Globe Introducer (601-01001)	Jun 03, 2025	Substantially Equivalent	Kardium, Inc.
K233248	FARADRIVE Steerable Sheath	Dec 11, 2023	Substantially Equivalent	Boston Scientific Corporation
K232321	FlexCath Contour Steerable Sheath	Oct 31, 2023	Substantially Equivalent	Medtronic, Inc.
K223824	POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor	Mar 22, 2023	Substantially Equivalent	Boston Scientific Corporation
K221397	MitraClip G4 Steerable Guide Catheter	Sep 28, 2022	Substantially Equivalent	ABBOTT MEDICAL
K221044	AcQGuide® VUE Steerable Sheath	May 05, 2022	Substantially Equivalent	Acutus Medical, Inc.
K211100	AcQGuide MAX Steerable Sheath	May 14, 2021	Substantially Equivalent	Acutus Medical, Inc.
K202620	FlexCath Advance Steerable Sheath and Dilator	Nov 13, 2020	Substantially Equivalent	Medtronic Cryocath, LP
K192422	Steerable Introducer 12F	Oct 04, 2019	Substantially Equivalent	Freudenberg Medical, LLC
K190167	MitraClip G4 Steerable Guide Catheter	May 29, 2019	Substantially Equivalent	Abbott
K183174	FlexCath Advance Steerable Sheath and Dilator	Nov 26, 2018	Substantially Equivalent	Medtronic Cryocath, LP
K172394	Steerable Guide Catheter	Sep 06, 2017	Substantially Equivalent	Abbott Vascular
K162925	AcQGuide Steerable Sheath	Apr 06, 2017	Substantially Equivalent	Acutus Medical, Inc.
K160919	Hansen Medical Magellan Robotic Catheter 9Fr	Sep 20, 2016	Substantially Equivalent	Hansen Medical, Inc.
K161985	Steerable Guide Catheter	Aug 07, 2016	Substantially Equivalent	Abbott Vascular
K152310	HeartLight Deflectable Sheath	Feb 24, 2016	Substantially Equivalent	Cardiofocus, Inc.
K153304	Hansen Medical Magellan Robotic Catheter eKit	Feb 01, 2016	Substantially Equivalent	Hansen Medical, Inc.
K151463	Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components	Aug 18, 2015	Substantially Equivalent	Hansen Medical, Inc.
K133552	MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT	Feb 07, 2014	Substantially Equivalent	Hansen Medical
K123591	FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)	Dec 27, 2012	Substantially Equivalent	Medtronic Cryocath, LP
K122275	ARTISAN EXTEND CONTROL CATHETER	Aug 29, 2012	Substantially Equivalent	Hansen Medical
K120086	CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM	Apr 24, 2012	Substantially Equivalent	Cardiosolutions
K112541	Z FLEX-270TM STEERABLE SHEATH	Feb 07, 2012	Substantially Equivalent	Great Batch Medical
K112239	STEERABLE GUIDE CATHETER	Aug 31, 2011	Substantially Equivalent	Abbott Vascular
K102176	FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10	Sep 01, 2010	Substantially Equivalent	Medtronic Cryocath, LP
K100789	MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST	Apr 21, 2010	Substantially Equivalent	Evalve, Inc.
K093866	EVALVE STEERABLE GUIDE CATHETER	Jan 13, 2010	Substantially Equivalent	Evalve, Inc.
K091596	EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST	Jul 02, 2009	Substantially Equivalent	Evalve, Inc.
K083793	STEERABLE GUIDE CATHETER	Apr 27, 2009	Substantially Equivalent	Evalve, Inc.
K081049	FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12	Jun 27, 2008	Substantially Equivalent	Cryocath Technologies, Inc.
K070357	FLEXCATH STEERABLE SHEATH & DILATOR	Dec 28, 2007	Substantially Equivalent	Cryocath Technologies, Inc.
K052575	LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN	Jan 19, 2006	Substantially Equivalent	St Jude Medical
K050472	LYSUS INFUSION SYSTEM	Mar 11, 2005	Substantially Equivalent	Ekos Corp.
K040165	REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805	May 12, 2004	Substantially Equivalent	St Jude Medical
K012143	24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524	Oct 24, 2001	Substantially Equivalent	Medtronic Cardiac Surgical Products
K924227	CRI CYNOSAR CATHETER	Jun 29, 1993	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius
K913940	RESPONSE(TM) STEERABLE CATHETER	Jan 26, 1993	Substantially Equivalent	Daig Corp.
K904785	CRI CYNOSAR CATHETER	Mar 06, 1991	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius
K900320	CRI CYNOSAR CATHETER	Sep 14, 1990	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius
K884337	MICRO-GUIDE SYSTEM	Jan 05, 1989	Substantially Equivalent	Catheter Research C/O Burditt, Bowles & Radzius
K834352	ADULT VENT CATHETER	Jan 27, 1984	Substantially Equivalent	Dlp, Inc.