FDA.reportPublic FDA data

MO.MA ULTRA

Primary DI
08033477050140
Brand
MO.MA ULTRA
Company
MEDTRONIC, INC.
Model
MUS0130069X6
Device description
Cath MUS0130069X6 CPD Ultra US 9F UL950
Published
2016-05-08
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
NTETemporary Carotid Catheter for Embolic Capture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTETemporary Carotid Catheter For Embolic CaptureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092177000MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6Invatec S.P.A.2009-10-15NTE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033477050140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033477050140080334770501408033477050140

GMDN Terms#

Term, Definition table
TermDefinition
Carotid artery embolic protection systemAn assembly of devices intended to provide cerebrovascular embolic protection during carotid artery angioplasty and stenting procedures. It is available in various configurations and typically includes a sheath/catheter(s), intravascular balloon(s), guidewire, and extracorporeal valves/filters. The assembly is introduced into an artery percutaneously and used to produce blockage of blood through balloon inflation, typically at the carotid bifurcation and internal carotid artery to prevent distal embolization by particulate debris/thrombus and allow removal of debris/thrombus by blood filtration or aspiration. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429117224Nanoparasol, Peel AwayMicrovention, Inc.NTE2025-08-01
00842429117231Nanoparasol, Peel AwayMicrovention, Inc.NTE2025-08-01
00851616007149Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007156Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007293PaladinContego Medical, Inc.NTE2023-09-05
00851616007385Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007453Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007460Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007477PaladinContego Medical, Inc.NTE2023-09-05
00851616007538Vanguard Contego Medical, Inc.NTE2023-09-05
00851616007002PaladinContego Medical, Inc.NTE2023-09-05
00851616007309PaladinContego Medical, Inc.NTE2023-09-05
00811311021062ENROUTE Transcarotid Neuroprotection SystemBOSTON SCIENTIFIC CORPORATIONNTE2023-04-24
10705032053501ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032053556ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032054805ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032055819ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056748ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056793ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056830ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056854ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056892ANGIOGUARDCordis US Corp.NTE2022-04-11
10705032056939ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
10705032056946ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032053508ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032053553ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032054802ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032055816ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056745ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11
20705032056790ANGIOGUARDCORDIS CORPORATIONNTE2022-04-11