FDA.reportPublic FDA data

Apollo

Primary DI
00763000446758
Brand
Apollo
Company
Micro Therapeutics, Inc.
Model
105-5096-000
Device description
MICRO CATH 105-5096-000 V08 APOLLO 3.0CM
Published
2022-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
P030004026

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030004026ONYX LIQUID EMBOLIC SYSTEMEv3 Neurovascular2005-07-21MFE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000446758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000446758007630004467587630004467580763000446758

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Device should be stored in a dry place, away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
826110710
Device count
1
Lot or batch
true

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
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
00847536006010ApolloTMMicro Therapeutics, Inc.MFE2016-09-26
00847536006041ApolloTMMicro Therapeutics, Inc.MFE2016-09-26
00836462002463Apollo OnyxMicro Therapeutics, Inc.MFE2015-06-08
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