FDA.reportPublic FDA data

Excimer Laser System

Primary DI
00813132029937
Brand
Excimer Laser System
Company
Spectranetics Corporation
Model
CVX-300-P
Catalog number
CVX-300-P
Published
2022-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPCDevice, Angioplasty, Laser, Coronary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPCDevice, Angioplasty, Laser, CoronaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P910001033

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910001033SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEMSpectranetics Corp.1993-02-19LPC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M204CVX300PAA0PreviousHIBCC0
00813132029937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132029937008131320299378131320299370813132029937

GMDN Terms#

Term, Definition table
TermDefinition
Atherectomy excimer laser systemA mobile, mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic, electromagnetic (EM) radiation intended for the intraluminal photoablation or debulking of vascular lesion material (blockages, total occlusions) and sometimes to photoablate tissue attached to the leads of active implantable devices. It is intended to be used with an angioplasty catheter and typically consists of an electrical unit with a display, controls and/or foot-switch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-633-0960complaints@spnc.com

Regulatory Flags#

DUNS number
151047370
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813132020293SLS II Laser Sheath500-001500-0012015-02-06
00813132020309SLS II Laser Sheath500-012500-0122015-02-06
00813132020316SLS II Laser Sheath500-013500-0132015-02-06
00813132020903SightRail Manual Dilator Sheath550-008550-0082015-02-06
00813132020910SightRail Manual Dilator Sheath550-010550-0102015-02-06
00813132020927SightRail Manual Dilator Sheath550-011550-0112015-02-06
00813132020934SightRail Manual Dilator Sheath550-013550-0132015-02-06
00813132020941SightRail Manual Dilator Sheath555-508555-5082015-02-06
00813132020958SightRail Manual Dilator Sheath555-510555-5102015-02-06
00813132020965SightRail Manual Dilator Sheath555-511555-5112015-02-06
00813132020972SightRail Manual Dilator Sheath555-513555-5132015-02-06
00813132020002ELCA™110-001AA110-0012015-02-06
00813132020019ELCA™110-002AA110-0022015-02-06
00813132020026ELCA™110-003AA110-0032015-02-06
00813132020064ELCA™117-205AA117-2052015-02-06
00813132020071ELCA™120-008AA120-0082015-02-06
00813132025410ELCA™120-008AB120-0082017-12-04
00813132025427ELCA™117-205AB117-2052017-12-04
00813132025465ELCA™110-003AB110-0032017-12-04
00813132025472ELCA Coronary Laser Atherectomy Catheter110-002110-0022017-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813132027452Philips Laser SystemSpectranetics CorporationLPC2021-09-20
00813132025403ELCA Coronary Laser Atherectomy CatheterSpectranetics CorporationLPC2017-12-04
00813132025410ELCA™Spectranetics CorporationLPC2017-12-04
00813132025427ELCA™Spectranetics CorporationLPC2017-12-04
00813132025434ELCA Coronary Laser Atherectomy CatheterSpectranetics CorporationLPC2017-12-04
00813132025441ELCA Coronary Laser Atherectomy CatheterSpectranetics CorporationLPC2017-12-04
00813132025458ELCA Coronary Laser Atherectomy CatheterSpectranetics CorporationLPC2017-12-04
00813132025465ELCA™Spectranetics CorporationLPC2017-12-04
00813132025472ELCA Coronary Laser Atherectomy CatheterSpectranetics CorporationLPC2017-12-04
00813132025489ELCA™Spectranetics CorporationLPC2017-12-04
M204CVX300PAA0CVX-300®-PSpectranetics CorporationLPC2017-01-20
00813132020002ELCA™Spectranetics CorporationLPC2015-02-06
00813132020019ELCA™Spectranetics CorporationLPC2015-02-06
00813132020026ELCA™Spectranetics CorporationLPC2015-02-06
00813132020033ELCA™Spectranetics CorporationLPC2015-02-06
00813132020040ELCA™Spectranetics CorporationLPC2015-02-06
00813132020057ELCA™Spectranetics CorporationLPC2015-02-06
00813132020064ELCA™Spectranetics CorporationLPC2015-02-06
00813132020071ELCA™Spectranetics CorporationLPC2015-02-06
00813132020088ELCA™Spectranetics CorporationLPC2015-02-06
M204110001AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204110002AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204110003AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204110004AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204114009AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204117016AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204117205AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204120008AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204120009AA0ELCA™Spectranetics CorporationLPC2015-02-06
M204CVX3000Excimer Laser SystemSpectranetics CorporationLPC2014-08-26