FDA.reportPublic FDA data

CPS DIRECT™

Primary DI
05415067003775
Brand
CPS DIRECT™
Company
ST. JUDE MEDICAL, INC.
Model
DS2M022
Catalog number
DS2M022
Device description
MediGuide Enabled Slittable Outer Guide Catheter
Published
2016-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCATHETER, PERCUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120296000CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETERSt. Jude Medical, Cardiac Rhythm Management Divisi2012-05-11DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067003775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067003775054150670037755415067003775

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00Store in a cool, dark, dry place. Do not crush.
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067057341Navitor™NVRO-35NVRO-352026-11-05
05415067057365Navitor™NVRO-29NVRO-292026-11-05
05415067057389Navitor™NVRO-27NVRO-272026-11-05
05415067057402Navitor™NVRO-25NVRO-252026-11-05
05415067057426Navitor™NVRO-23NVRO-232026-11-05
05415067057242Amplatzer™9-APVL-1439-APVL-1432026-11-02
05415067057259Amplatzer™9-APVL-0849-APVL-0842026-11-02
05415067057266Amplatzer™9-APVL-1239-APVL-1232026-11-02
05415067057273Amplatzer™9-APVL-0639-APVL-0632026-11-02
05415067057280Amplatzer™9-APVL-1059-APVL-1052026-11-02
05415067057297Amplatzer™9-APVL-0429-APVL-0422026-11-02
05415067057303Amplatzer™9-APVL-1039-APVL-1032026-11-02
05415067057310Amplatzer™9-APVL-1259-APVL-1252026-11-02
05415067057327Amplatzer™9-APVL-1459-APVL-1452026-11-02
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552777687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.DQY2026-10-29
07613327682427Excelsior ReachStryker CorporationDQY2026-10-29
07613327682434Excelsior ReachStryker CorporationDQY2026-10-29
07613327682441Excelsior ReachStryker CorporationDQY2026-10-29
07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
08718122024218Climber Guiding CatheterPendraCare International B.V.DQY2026-05-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00884450838167Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
00884450838174Ventrax™Merit Medical Systems, Inc.DQY2026-01-13