Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007284006

FEI Number

3007284006

Entity Name

SPECTRANETICS CORP.

City/State/Country

Colorado Springs, CO, US

Establishment Address

9965 Federal Drive, Colorado Springs, CO 80921, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2939520)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043401

PMA Number

N/A

All Registered Proprietary Names

LLD EZ Lead Locking Device Bridge Occlusion Balloon Turbo-Elite Laser Atherectomy Catheter Turbo-Power Laser Atherectomy Catheter TightRail Mini Rotating Dilator Sheath TightRail Rotating Dilator Sheath TightRail Sub-C Rotating Dilator Sheath Phoenix Atherectomy System 2.2mm x 149cm Phoenix Atherectomy System 1.8mm x 149cm Phoenix Atherectomy Catheter 1.8mm x 149cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter 2.2mm x 149cm Turbo-Elite Laser Atherectomy Catheter Bridge Prep Kit GlideLight Laser Sheath Quick-Cross Support Catheter Bridge Occlusion Balloon TorqMax Sheath Grip Accessory Phoenix Atherectomy Catheter 2.4mm x 130cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy System 2.4mm x 130cm Turbo-Power Laser Atherectomy Catheter Bridge Plus Occlusion Balloon Catheter Phoenix Floppy Tip, Extra Support Guidewire Phoenix Floppy Tip, Light Support Guidewire ELCA Coronary Laser Atherectomy Catheter CVX-300 Excimer Laser System Philips Laser System Phoenix Deflecting Atherectomy System 2.4mm x 127cm Phoenix Handle with Wire Support Clip Quick-Cross Support Catheter CavaClear Laser Sheath VisiSheath Dilator Sheath QuickCat Extraction Catheter Phoenix Handle with Wire Support Clip Phoenix Pre-Deflected Atherectomy System 2.2mm x 130cm Phoenix Pre-Deflected Atherectomy Catheter 2.2mm x 130cm SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 Phoenix Atherectomy System 2.2mm x 130cm Phoenix Atherectomy System 1.8mm x 130cm Phoenix Atherectomy Catheter 2.2mm x 130cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter 1.8mm x 130cm LLD E Lead Locking Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2018-11-26
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2022-05-16
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-09
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-10-09
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2019-09-26
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2018-11-26
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-05-21
PDU	Catheter For Crossing Total Occlusions	Cardiovascular	Class 2	870.1250	2018-11-26
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2018-11-26
MFA	Device, Removal, Pacemaker Electrode, Percutaneous	Unknown	Class 3	N/A	2018-11-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-11-26
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2018-11-26
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2018-11-26
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2017-09-25
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-09-14
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2025-09-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-03-15
LPC	Device, Angioplasty, Laser, Coronary	Unknown	Class 3	N/A	2018-11-26
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2016-10-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-11-26
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Cardiovascular	Class 2	870.5125	2022-02-23
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2018-11-26
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2018-11-26
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-03-15
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2019-09-26
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2016-10-25
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2018-11-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25
K071227	Spectranetics Corp.	CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15	2007-07-11
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007284006. Last updated year: 2026. Please use registration number 3007284006 when referencing this establishment in official correspondence.