FDA.reportPublic FDA data

AxiumTM

Primary DI
00847536017153
Brand
AxiumTM
Company
Micro Therapeutics, Inc.
Model
QC-1.5-1-HELIX
Device description
QC-1.5-1-HELIX BARE AXIUM 1.5MM X 1CM
Published
2015-09-07
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
HCGDEVICE, NEUROVASCULAR EMBOLIZATION
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133310000AXIUM DETACHABLE COIL SYSTEMMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2014-01-10HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847536017153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847536017153008475360171538475360171530847536017153

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry cool place not to exceed 50 degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847536003446Echelon103-50952015-10-23
00763000541194RistTM106F-071-952022-05-01
00763000541200RistTM106F-071-1002022-05-01
00763000541217RistTM106F-071-1052022-05-01
00763000413767Rist™107F-079-952020-10-05
00763000413774Rist™107F-079-1002020-10-05
00763000413781Rist™107F-079-1052020-10-05
00763000413798Rist™105F-BER-1202020-10-05
00763000413804Rist™105F-BER-1302020-10-05
00763000413811Rist™105F-SIM-1202020-10-05
00763000413828Rist™105F-SIM-1302020-10-05
00763000399641PhenomTM 17 CatheterFG11150-0615-2J2021-04-26
00763000399658PhenomTM 17 CatheterFG11150-0615-2R2021-04-26
00763000399665PhenomTM 17 CatheterFG11150-0615-2S2021-04-26
00763000399672PhenomTM 17 CatheterFG11150-0615-2X2021-04-26
00763000399689PhenomTM 21 CatheterFG13150-0615-2S2021-04-26
00763000399702PhenomTM 27 CatheterFG15150-0615-1S2021-04-26
00763000399719PhenomTM 27 CatheterFG15150-0630-1S2021-04-26
00763000399733PhenomTM Plus CatheterFG19120-1030-1S2021-04-26
00847536041967REACT™REACT-682021-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04546540688897GDC-10Stryker CorporationHCG2015-09-21
04546540688910GDC-10Stryker CorporationHCG2015-09-21
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04546540689054GDC-10Stryker CorporationHCG2015-09-21
04546540689061GDC-10Stryker CorporationHCG2015-09-21
04546540689078GDC-10Stryker CorporationHCG2015-09-21
04546540689085GDC-10Stryker CorporationHCG2015-09-21
04546540689092GDC-10Stryker CorporationHCG2015-09-21
04546540689108GDC-10Stryker CorporationHCG2015-09-21
04546540689115GDC-10Stryker CorporationHCG2015-09-21
04546540689122GDC-10Stryker CorporationHCG2015-09-21
04546540689139GDC-10Stryker CorporationHCG2015-09-21
04546540689146GDC-10Stryker CorporationHCG2015-09-21
04546540689153GDC-10Stryker CorporationHCG2015-09-21
04546540689160GDC-10Stryker CorporationHCG2015-09-21
04546540689177GDC-10Stryker CorporationHCG2015-09-21
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04546540689207GDC-10Stryker CorporationHCG2015-09-21
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04546540689221GDC-10Stryker CorporationHCG2015-09-21
04546540689238GDC-10Stryker CorporationHCG2015-09-21
04546540689245GDC-10Stryker CorporationHCG2015-09-21
04546540689252GDC-10Stryker CorporationHCG2015-09-21
04546540689269GDC-10Stryker CorporationHCG2015-09-21
04546540689276GDC-10Stryker CorporationHCG2015-09-21
04546540689283GDC-10Stryker CorporationHCG2015-09-21
04546540689290GDC-10Stryker CorporationHCG2015-09-21
04546540689306GDC-10Stryker CorporationHCG2015-09-21