Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004742232

FEI Number

3004742232

Entity Name

Cardiovascular Systems Incorporated

City/State/Country

Saint Paul, MN, US

Establishment Address

1225 Old Highway 8 NW, Saint Paul, MN 55112, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203008

PMA Number

N/A

All Registered Proprietary Names

ViperTrack 20 Max Crown Diamondback 360® Peripheral Orbital Atherectomy Stealth 360 PAD System Stealth OAS Diamondback OAS Diamondback ViperCross Support Catheters DIAMONDBACK 360 Peripheral Orbital Atherectomy System Diamondback Peripheral Micro ViperSlide Lubricant Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series VIPERWIRE ADVANCE with FLEXTIP Peripheral Atherectomy Guidewire ViperCath XC Peripheral Exchange Catheter WIRION Embolic Protection System DiamondBack 360 Peripheral Orbital Atherectomy System, Exchangeable Stealth 360 Peripheral Orbital Atherectomy System DiamondBack 360 Peripheral Orbital Atherectomy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2008-09-19
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-07-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-12-09
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2011-11-29
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-30
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2018-12-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-08-30
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-12-04
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-31
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2012-01-16
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-30
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-12-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-01-03
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2021-03-04
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2020-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
3007031057	MERCIAN SURGICAL SUPPLY CO LTD	Bromsgrove Worcestershire, GB
3011693567	LAMINATE MEDICAL TECHNOLOGIES	Tel Aviv, IL
3009134882	DMED	Seongnam-si Gyeonggi, KR
1057425	SOUTHEASTERN TECHNOLOGY dba Autocam Medical	Murfreesboro, TN, US
8044098	HGR INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004742232. Last updated year: 2026. Please use registration number 3004742232 when referencing this establishment in official correspondence.