FDA.reportPublic FDA data

Protege RX Tapered

Primary DI
00821684038727
Brand
Protege RX Tapered
Company
Covidien LP
Model
SECX-10-7-40-135
Device description
Carotid Stent System
Published
2014-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIMSTENT, CAROTID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIMStent, CarotidUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060001019
P060001033

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060001019PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMSMedtronic Vascular, Inc.2007-01-24NIM
P060001033PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMSMedtronic Vascular, Inc.2007-01-24NIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684038727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684038727008216840387278216840387270821684038727

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Device Size Text, specify0
Length40Millimeter
Outer Diameter2Millimeter
Outer Diameter7Millimeter
Outer Diameter10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
968903703
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

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