FDA.reportPublic FDA data

ELCA™

Primary DI
00813132020033
Brand
ELCA™
Company
Spectranetics Corporation
Model
110-004AA
Catalog number
110-004
Device description
ELCA™ Coronary Laser Atherectomy Catheter
Published
2015-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
P910001019

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910001019SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEMSpectranetics Corp.1993-02-19LPC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813132020033PrimaryGS10
M204110004AA0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132020033008131320200338131320200330813132020033

GMDN Terms#

Term, Definition table
TermDefinition
Atherectomy laser system beam guide-catheter, coronaryA sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the coronary arteries for the ablation of atherosclerotic plaques in completely occluded vessels. It typically consists of fibreoptic materials with a laser-firing distal end and allows the treatment to be made without significant thermal effect. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.97Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
151047370
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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
00813132029937Excimer Laser SystemSpectranetics CorporationLPC2022-10-12
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
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