FDA.reportPublic FDA data

PIPELINE

Primary DI
00847536016866
Brand
PIPELINE
Company
Micro Therapeutics, Inc.
Model
PED-500-10
Device description
PED-500-10 PIPELINE FLEX 5.00MM X 10MM
Published
2015-04-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OUTIntracranial aneurysm flow diverter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUTIntracranial Aneurysm Flow DiverterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100018011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100018011PIPELINE EMBOLIZATION DEVICEMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-04-06OUT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536016866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536016866008475360168668475360168660847536016866

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA 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
Device Size Text, specify0
Length0

Contacts#

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

Regulatory Flags#

DUNS number
826110710
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
false
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
00847536036338PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-300-102023-12-31
00847536036390PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-300-252023-12-31
00847536036499PipelineTM Vantage Embolization Device with Shield TechnologyTMPED3-021-350-102023-12-31
00763000495626Axium™ Prime Detachable Coil SystemFC-9-20-3D2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemFC-9-30-3D2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemFC-10-30-3D2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemFC-10-40-3D2023-08-07
00763000488000Axium™ Detachable Coil SystemQC-2.5-2-HELIX2022-10-28
00763000488024Axium™ Detachable Coil SystemQC-2.5-6-HELIX2022-10-28
00763000488031Axium™ Detachable Coil SystemQC-2.5-8-HELIX2022-10-28
00763000488147Axium™ Detachable Coil SystemQC-7-30-HELIX2022-10-28
00763000488154Axium™ Detachable Coil SystemQC-8-20-HELIX2022-10-28
00763000488178Axium™ Detachable Coil SystemQC-9-20-HELIX2022-10-28
00763000488208Axium™ Detachable Coil SystemQC-10-30-HELIX2022-10-28
00763000488215Axium™ Detachable Coil SystemQC-12-30-HELIX2022-10-28
00763000488222Axium™ Detachable Coil SystemQC-12-40-HELIX2022-10-28
00763000488246Axium™ Detachable Coil SystemQC-14-40-HELIX2022-10-28
00763000488253Axium™ Detachable Coil SystemQC-16-30-HELIX2022-10-28
00763000488277Axium™ Detachable Coil SystemQC-18-40-HELIX2022-10-28
00763000488284Axium™ Detachable Coil SystemQC-20-40-HELIX2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429106570StentMicrovention, Inc.OUT2025-04-22
00842429106587StentMicrovention, Inc.OUT2025-04-22
00842429106594StentMicrovention, Inc.OUT2025-04-22
00842429106600StentMicrovention, Inc.OUT2025-04-22
00842429106617StentMicrovention, Inc.OUT2025-04-22
00842429106624StentMicrovention, Inc.OUT2025-04-22
00842429106631StentMicrovention, Inc.OUT2025-04-22
00842429106648StentMicrovention, Inc.OUT2025-04-22
00842429106655StentMicrovention, Inc.OUT2025-04-22
00842429106662StentMicrovention, Inc.OUT2025-04-22
00842429106679StentMicrovention, Inc.OUT2025-04-22
00842429106686StentMicrovention, Inc.OUT2025-04-22
00842429106693StentMicrovention, Inc.OUT2025-04-22
00842429106709StentMicrovention, Inc.OUT2025-04-22
00842429106723StentMicrovention, Inc.OUT2025-04-22
00842429106730StentMicrovention, Inc.OUT2025-04-22
00842429106747StentMicrovention, Inc.OUT2025-04-22
00842429106754StentMicrovention, Inc.OUT2025-04-22
00842429106761StentMicrovention, Inc.OUT2025-04-22
00842429106778StentMicrovention, Inc.OUT2025-04-22
00842429106785StentMicrovention, Inc.OUT2025-04-22
00842429106792StentMicrovention, Inc.OUT2025-04-22
00842429106808StentMicrovention, Inc.OUT2025-04-22
00842429106815StentMicrovention, Inc.OUT2025-04-22
00842429106822StentMicrovention, Inc.OUT2025-04-22
00842429106839StentMicrovention, Inc.OUT2025-04-22
00842429106846StentMicrovention, Inc.OUT2025-04-22
00842429106853StentMicrovention, Inc.OUT2025-04-22
00842429106860StentMicrovention, Inc.OUT2025-04-22
00763000448929Pipeline TM Flex Embolization Device with Shield Technology TMMicro Therapeutics, Inc.OUT2025-03-11