FDA.reportPublic FDA data

ELCA Coronary Laser Atherectomy Catheter

Primary DI
00813132025403
Brand
ELCA Coronary Laser Atherectomy Catheter
Company
Spectranetics Corporation
Model
120-009
Catalog number
120-009
Published
2017-12-04
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
P910001014

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P910001014SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEMSpectranetics Corp.1993-02-19LPC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813132025403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813132025403008131320254038131320254030813132025403

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length135Centimeter
Outer Diameter2Millimeter

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
(800) 228-4728IGTD.CustomerInquiry@philips.com

Regulatory Flags#

DUNS number
151047370
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M2045180320Quick-Cross™518-032518-0322014-08-19
M2045180330Quick-Cross™518-033518-0332014-08-19
M2045180340Quick-Cross™518-034518-0342014-08-19
M2045180350Quick-Cross™518-035518-0352014-08-19
M2045180360Quick-Cross™518-036518-0362014-08-19
M2045180370Quick-Cross™518-037518-0372014-08-19
M2045180380Quick-Cross™518-038518-0382014-08-19
M2045180430Turbo-Booster™518-043518-0432014-09-15
M2045180630Turbo-Booster™518-063518-0632014-09-15
M2045180650Quick-Cross™518-065518-0652014-08-19
M2045180660Quick-Cross™518-066518-0662014-08-19
M2045180760Quick-Cross™Extreme™518-076518-0762014-08-26
M2045180770Quick-Cross™Select518-077518-0772014-08-26
M2045180780Quick-Cross™Extreme™518-078518-0782014-08-26
M2045180790Quick-Cross™Select518-079518-0792014-08-26
M2045180800Quick-Cross™Extreme™518-080518-0802014-08-26
M2045180810Quick-Cross™Select518-081518-0812014-08-26
M2045180820Quick-Cross™Extreme™518-082518-0822014-08-26
M2045180830Quick-Cross™Select518-083518-0832014-08-26
M2045180840Quick-Cross™Extreme™518-084518-0842014-08-26

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
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