FDA.reportPublic FDA data

Innervision

Primary DI
00643169483873
Brand
Innervision
Company
MEDTRONIC PS MEDICAL, INC.
Model
27065 D
Device description
CATH 27065 D VENT SNAP ENDO 7CM
Published
2015-06-25
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
LKGPORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983331000MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102Medtronic PS Medical1998-12-16HCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169483873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169483873006431694838736431694838730643169483873

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
089055867
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20763000467382NA464402024-02-26
00763000406080NA273022024-02-26
00763000624798Duet®469162022-03-10
00763000624804Duet®469172022-03-10
00763000406028Duet®469172021-02-07
00763000396008Duet®469152021-01-24
00763000343149N/A200342020-04-20
00763000029449N/A8023 B2020-03-07
00763000030827N/A250772020-03-08
00643169483316NA8023 B2015-06-24
00643169498365NA250772015-07-14
00643169507517NA8023 A2015-06-25
00643169073623NA250772015-06-25
00643169466142N/A461412015-07-15
00673978228969NA464222015-06-18
00673978246017NA272972015-07-21
00673978246031NA273022015-07-14
20643169466122N/A464402015-07-15
00763000422646StrataMR246955MR2026-03-13
00763000422684StrataMR246957MR2026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000980849ReservoirMEDTRONIC POWERED SURGICAL SOLUTIONSLKG2025-08-03
00763000980863ReservoirMicro Therapeutics, Inc.LKG2025-08-03
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