FDA.reportPublic FDA data

EverFlex

Primary DI
00821684069530
Brand
EverFlex
Company
EV3, INC
Model
PRB35-08-080-080
Device description
STENT PRB35-08-080-080 PROTEGE EF V10
Published
2015-05-27
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
FGEStents, drains and dilators for the biliary ducts
NIPSTENT, SUPERFICIAL FEMORAL ARTERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
NIPStent, Superficial Femoral ArteryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060057000
P110023000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060057000PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEMEv3, Inc.2006-03-08FGE
P110023000EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)Medtronic Vascular, Inc.2012-03-07NIP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821684069530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821684069530008216840695308216840695300821684069530

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge6French
Length80Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
117446916
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150028399Liberant™LMT-TRX2026-05-07
00821684071397Protégé™ GPS™SERB65-09-20-1202015-09-04
00821684071403Protégé™ GPS™SERB65-09-20-802015-09-04
00821684071410Protégé™ GPS™SERB65-09-30-1202015-09-04
00821684071427Protégé™ GPS™SERB65-09-30-802015-09-04
00821684071434Protégé™ GPS™SERB65-09-40-1202015-09-04
00821684071441Protégé™ GPS™SERB65-09-40-802015-09-04
00821684071458Protégé™ GPS™SERB65-09-60-1202015-09-04
00821684071465Protégé™ GPS™SERB65-09-60-802015-09-04
00821684071472Protégé™ GPS™SERB65-09-80-1202015-09-04
00821684071489Protégé™ GPS™SERB65-09-80-802015-09-04
00821684071496Protégé™ GPS™SERB65-10-20-1202015-09-01
00821684071502Protégé™ GPS™SERB65-10-20-802015-09-01
00821684071519Protégé™ GPS™SERB65-10-30-1202015-09-01
00821684071526Protégé™ GPS™SERB65-10-30-802015-09-01
00821684071533Protégé™ GPS™SERB65-10-40-1202015-09-01
00821684071540Protégé™ GPS™SERB65-10-40-802015-09-01
00821684071557Protégé™ GPS™SERB65-10-60-1202015-09-01
00821684071564Protégé™ GPS™SERB65-10-60-802015-09-01
00821684071571Protégé™ GPS™SERB65-10-80-1202015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FGE2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FGE2026-04-15