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Advanced Cardiovascular Systems, Inc.

USA · Mountain View

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 4 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 1Class II 3Class III 1

plus 34 registration records and 131 510(k), 272 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

2 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

16active device licences

Class II 5Class III 1Class IV 10

18 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States34 registration records, 131 510(k), 272 PMA, 45 excluded

Brazil0 confirmed, 6 excluded

Canada16 confirmed, 9 excluded

Manufacturer names merged into this page: Cardiovascular Systems Incorporated · CARDIOVASCULAR SYSTEMS INCORPORATED · GUIDANT ADVANCED CARDIOVASCULAR SYSTEMS INC. · CARDIOVASCULAR SYSTEMS INC. · CARDIOVASCULAR SYSTEMS, INC

FDA 510(k) clearances by year

31996

11997

21999

22000

12002

12005

42007

22008

12009

22011

12012

12013

12014

22015

12017

32018

12019

22020

52021

12022

FDA listed device types

Catheter, Peripheral, Atherectomy 1Catheter, Percutaneous 1Temporary Carotid Catheter For Embolic Capture 1Tape, Measuring, Rulers And Calipers 1Catheter, Coronary, Atherectomy 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220109	DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System	2022-03-01
US	K212725	ViperCross Support Catheters	2021-09-24
US	K210586	Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system	2021-09-14
CA	228	ACS RX GEMINI CORONARY DILATATION CATHETER	Class IV
CA	236	ACS RX SOLARIS CORONARY DILATATION CATHETER	Class IV
CA	7407	ACS SWAP-IT GUIDE WIRE EXCHANGE DEVICE	Class II

Advanced Cardiovascular Systems, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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