FDA.reportPublic FDA data

Pipeline

Primary DI
00836462014329
Brand
Pipeline
Company
Micro Therapeutics, Inc.
Model
FA-77350-10
Catalog number
FA-77350-10
Device description
Embolization Device
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
OUTIntracranial aneurysm flow diverter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUTIntracranial Aneurysm Flow DiverterUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100018004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100018004PIPELINE EMBOLIZATION DEVICEMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-04-06OUT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462014329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462014329008364620143298364620143290836462014329

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
Length10Millimeter
Outer Diameter3.5Millimeter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150045532OnyxTM Liquid Embolic System (LES)105-7100-0602026-06-07
00763000488017Axium™ Detachable Coil SystemQC-2.5-4-HELIX2022-10-28
00763000488192Axium™ Detachable Coil SystemQC-10-20-HELIX2022-10-28
00763000488239Axium™ Detachable Coil SystemQC-14-30-HELIX2022-10-28
00763000488260Axium™ Detachable Coil SystemQC-16-40-HELIX2022-10-28
00763000488727Axium™ Detachable Coil SystemQC-25-50-3D2022-10-28
00763000488796Axium™ Detachable Coil SystemNC-3-4-HELIX2022-10-28
00763000488826Axium™ Detachable Coil SystemNC-4-8-HELIX2022-10-28
00763000488864Axium™ Detachable Coil SystemPC-2-3-HELIX2022-10-28
00763000488932Axium™ Detachable Coil SystemPC-4-8-HELIX2022-10-28
00763000488994Axium™ Detachable Coil SystemPC-7-20-HELIX2022-10-28
00763000489052Axium™ Detachable Coil SystemPC-10-20-HELIX2022-10-28
00763000489076Axium™ Detachable Coil SystemPC-2-2-3D2022-10-28
00763000489137Axium™ Detachable Coil SystemPC-4-6-3D2022-10-28
00847536032866AxiumTMNC-2-6-HELIX2019-06-29
00847536033306AxiumTMPC-6-15-3D2019-06-29
00847536033368AxiumTMPC-8-20-3D2019-06-29
00847536029668AxiumTMQC-8-30-HELIX2019-06-20
00847536029729AxiumTMQC-12-40-HELIX2019-06-20
00847536029781AxiumTMQC-20-40-HELIX2019-06-20

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