Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008814558

FEI Number

3008814558

Entity Name

CARDIOVASCULAR SYSTEMS INCORPORATED

City/State/Country

Houston, TX, US

Establishment Address

14740 Kirby Dr, Houston, TX 77047, 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

K150732

PMA Number

N/A

All Registered Proprietary Names

Stealth OAS Diamondback OAS Diamondback Peripheral Micro 20 Max Crown Diamondback Peripheral Micro Stealth 360 PAD System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Viperwire Advance with Flextip DIAMONDBACK 360 Peripheral Orbital Atherectomy System DIAMONDBACK 360 Coronary Orbital Atherectomy System Diamondback 360® Peripheral Orbital Atherectomy DIAMONDBACK 360 Peripheral Orbital Atherectomy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-30
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-31
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-07-14
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-31
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	2018-06-15
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-12-04
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2013-10-28
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-12-09
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-12-04

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

Similar Registrations

Registration Number	Establishment Name	Location
3003862657	REX MEDICAL LP	CONSHOHOCKEN, PA, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
2011171	Sterigenics US LLC	Los Angeles, CA, US
3012669557	LIGHT GUIDE OPTICS INTERNATIONAL LTD.	Livani Preilu Novads, LV

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008814558. Last updated year: 2026. Please use registration number 3008814558 when referencing this establishment in official correspondence.