FDA.reportPublic FDA data

Cordis PRECISE PRO Rx Nitinol Stent System

Primary DI
20705032036440
Brand
Cordis PRECISE PRO Rx Nitinol Stent System
Company
Cordis US Corp.
Model
PC0720RXC
Catalog number
PC0720RXC
Published
2014-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIMSTENT, CAROTID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIMStent, CarotidUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030047025

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030047025CORDIS PRECISE NITINOL STENT SYSTEMCordis US Corporation2006-09-22NIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032036440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503203644020705032036440

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal carotid artery stentA sterile non-bioabsorbable tubular device intended to be implanted in a carotid artery of the neck to maintain arterial patency and improve luminal diameter in patients with atherosclerotic carotid artery disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100830VISTA BRITE TIP670-040-00M670-040-00M2024-09-09
10705032100892VISTA BRITE TIP778-034-00M778-034-00M2024-09-09
10705032100922VISTA BRITE TIP670-008-00M670-008-00M2024-09-09
10705032100953VISTA BRITE TIP778-270-00M778-270-00M2024-09-09
10862028000434MYNX CONTROLMX6760MX67602018-10-22
10862028000427MYNX CONTROLMX5060MX50602018-10-22
10705032009768AVANTI504405X504405X2016-08-01
10705032009775AVANTI504406X504406X2016-08-01
10705032009799AVANTI504408X504408X2016-08-01
10705032009881AVANTI504509X504509X2016-08-01
10705032009898AVANTI504604A504604A2016-08-01
10705032009904AVANTI504604P504604P2016-08-01
10705032009911AVANTI504604S504604S2016-08-01
10705032009935AVANTI504604X504604X2016-08-01
10705032009942AVANTI504605A504605A2016-08-01
10705032009959AVANTI504605P504605P2016-08-01
10705032009966AVANTI504605S504605S2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811425020852Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020869Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020876Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020883Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020890Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020906Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020913Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020920Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020937Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425020944Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024652Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024669Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024676Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024683Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024690Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024706Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
00811425024713Roadsaver Carotid Atery StentMicrovention, Inc.NIM2025-08-01
07290120281691CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281707CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281738CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281745CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281776CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281783CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281899CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281905CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281936CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281943CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281974CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
07290120281981CGuard Prime Carotid Stent SystemINSPIRE M.D LTDNIM2025-07-02
08717648356704XACT™ABBOTT VASCULAR INC.NIM2025-04-17