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Spectranetics Corporation

USA · Colorado Springs

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

14listed device types

Class I 0Class II 11Class III 3

plus 33 registration records and 44 510(k), 183 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

9active device licences

Class II 5Class IV 4

17 including historic records

TWTaiwanTFDA

8valid device licences

Class II 6Class III 2

SGSingaporeHSA SMDR

5device registrations

CLASS B 2CLASS D 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

8active ARTG entries

Class III 5IIa 1IIb 2

HKHong KongMDACS

4valid listings

Class II 1Class III 1Class IV 2

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

13active registrations

Class 2a 1Class 2b 2Class 3 10

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 States33 registration records, 44 510(k), 183 PMA

Brazil4 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: SPECTRANETICS CORP. · SPECTRANETICS CORPORATION · SPECTRANETICS, INC.

FDA 510(k) clearances by year

21999

12002

22004

42005

12006

32007

22008

42009

22010

12011

12013

62014

32015

22016

32017

12018

12020

12021

32022

12025

FDA listed device types

showing 8 of 14

Catheter, Peripheral, Atherectomy 1Laser-Powered Inferior Vena Cava Filter Retrieval Catheter 1Catheter Introducer Kit 1Wire, Guide, Catheter 1Stylet, Catheter 1Dilator, Vessel, For Percutaneous Catheterization 1Catheter For Crossing Total Occlusions 1Aspiration Thrombectomy Catheter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250385	Turbo-Elite Laser Atherectomy Catheter	2025-03-13
US	K223472	TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)	2022-12-15
US	K222837	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	2022-12-08
BR	10256400069	Dispositivo de Bloqueio de Eletrodo LLD	Class II
BR	10256400040	Bainha Dilatadora TightRail	Class II
BR	10256400043	Cateter Balão AngioSculpt PTA	Class II
CA	16679	LASER SHEATH KITS (HYTREL)	Class IV
CA	14069	PRIMA LASER GUIDEWIRE	Class II
CA	16678	VITESSE CII EXCIMER LASER ANGIOPLASTY CATHETER	Class IV