FDA.reportPublic FDA data

Reservoir

Primary DI
00763000980863
Brand
Reservoir
Company
Micro Therapeutics, Inc.
Model
24106 C
Device description
RESERVOIR 24106 C NEONT ANGULAR CATH 5CM
Published
2025-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKGPort & catheter, implanted, subcutaneous, intraventricular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKGPort & Catheter, Implanted, Subcutaneous, IntraventricularNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K874498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874498000CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.1988-02-11LKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000980863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000980863007630009808637630009808630763000980863

GMDN Terms#

Term, Definition table
TermDefinition
Cranial port/reservoirA sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device.

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
Lot or batch
true
Sterilization required before use
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
00763000980849ReservoirMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2025-08-03
00763000980856ReservoirMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2025-07-31
00763000028268N/AMEDTRONIC PS MEDICAL, INC.LKG2020-04-20
00763000028275N/AMEDTRONIC PS MEDICAL, INC.LKG2020-04-19
00763000030612N/AMicro Therapeutics, Inc.LKG2020-04-19
00763000030636N/AMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2020-04-19
00763000031107N/AMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2020-04-19
00382830055772Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00382830055826Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00382830056212Natus®NATUS MEDICAL INCORPORATEDLKG2020-04-03
00763000028237N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028244N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028251N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028503N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028510N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028527N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000028534N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029197N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029203N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029685N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029869InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029876InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029883InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029890InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029906InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029913InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000029920InnervisionMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030155N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030285N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20
00763000030292N/AMEDTRONIC PS MEDICAL, INC.LKG2020-03-20