FDA.reportPublic FDA data

PulseRider Aneurysm Neck Reconstruction Device

Primary DI
00859030005123
Brand
PulseRider Aneurysm Neck Reconstruction Device
Company
Medos International Sàrl
Model
213-D
Catalog number
213-D
Device description
Pulsar Vascular PulseRider,3.5 to 4.5mm,10mm,T shape
Published
2017-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJEIntracranial Neurovascular Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H160002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H160002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859030005123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859030005123008590300051238590300051230859030005123

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA sterile non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002552500xx@xx.xx
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034579689N/A6983451876983451872026-09-26
10705034579696N/A6983451886983451882026-09-26
10705034579702N/A6983451896983451892026-09-26
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859030005253PulseRiderMedos International SàrlNJE2019-09-17
00859030005260PulseRider Aneurysm Neck Reconstruction Device Connection CableMedos International SàrlNJE2019-09-17
00816777025982LVISMicrovention, Inc.NJE2018-11-25
00816777025999LVISMicrovention, Inc.NJE2018-11-25
00816777026002LVISMicrovention, Inc.NJE2018-11-25
00816777026019LVISMicrovention, Inc.NJE2018-11-25
00816777026026LVISMicrovention, Inc.NJE2018-11-25
00810170014420LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014437LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014451LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014468LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170016288LVISMicrovention, Inc.NJE2018-11-25
00810170016295LVISMicrovention, Inc.NJE2018-11-25
00810170016301LVISMicrovention, Inc.NJE2018-11-25
00810170016318LVISMicrovention, Inc.NJE2018-11-25
00810170016325LVISMicrovention, Inc.NJE2018-11-25
00810170016332LVISMicrovention, Inc.NJE2018-11-25
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00810170018961LVIS Jr.Microvention, Inc.NJE2018-11-25
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00810170018992LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170019005LVISMicrovention, Inc.NJE2018-11-25
00810170019012LVISMicrovention, Inc.NJE2018-11-25
00810170019029LVISMicrovention, Inc.NJE2018-11-25
00810170019036LVISMicrovention, Inc.NJE2018-11-25