FDA.reportPublic FDA data

Apollo Onyx

Primary DI
00836462002463
Brand
Apollo Onyx
Company
Micro Therapeutics, Inc.
Model
105-5095-000
Catalog number
105-5095-000
Device description
Delivery Micro Catheter
Published
2015-06-08
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
MFEAgent, injectable, embolic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MFEAgent, Injectable, EmbolicUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030004006

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030004006ONYX LIQUID EMBOLIC SYSTEMEv3 Neurovascular2005-07-21MFE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00836462002463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00836462002463008364620024638364620024630836462002463

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, is not a microcatheter (i.e., not intended to access superselective small vessels), and does not include a transseptal needle. It may include a disposable percutaneous introduction set. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length165Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

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
00199150045532OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-06-07
00199150045549OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-06-01
00763000925338OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-01-02
00763000925352OnyxTM Liquid Embolic System (LES)Micro Therapeutics, Inc.MFE2026-01-02
00763000446741ApolloMicro Therapeutics, Inc.MFE2022-11-13
00763000446758ApolloMicro Therapeutics, Inc.MFE2022-11-13
00847536006010ApolloTMMicro Therapeutics, Inc.MFE2016-09-26
00847536006041ApolloTMMicro Therapeutics, Inc.MFE2016-09-26
00836462002487Apollo OnyxMicro Therapeutics, Inc.MFE2015-06-08
00847536006171ONYX 18Micro Therapeutics, Inc.MFE2015-04-17
00847536006188ONYX 34Micro Therapeutics, Inc.MFE2015-04-17
00836462005044Onyx 18Micro Therapeutics, Inc.MFE2014-09-22
00836462005051Onyx 34Micro Therapeutics, Inc.MFE2014-09-22