FDA.reportPublic FDA data

Ventricular vent catheter

Primary DI
10803622106443
Brand
Ventricular vent catheter
Company
LIVANOVA USA, INC.
Model
VT-xxxxx
Published
2015-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981601000CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETERSorin Group Italia S.R.L.1998-07-28DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622106443PackageGS110In Commercial Distribution
00803622106446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362210644310803622106443
00803622106446008036221064468036221064460803622106446

GMDN Terms#

Term, Definition table
TermDefinition
Heart ventricle cannulaA sterile, rigid or semi-rigid tube designed to be surgically inserted into a cardiac ventricle. This is typically done directly during a surgical procedure and advanced until its distal tip is inside the cardiac ventricle. This device will serve as a channel intended for connection to an external device, such as left or right ventricular assist system. Some types may be used for temporary decompression of the left ventricle. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622164378Perfusion PackPerfusion Pack2026-09-22
00803622164477Perfusion PackPerfusion Pack2026-09-22
00803622164514Perfusion PackPerfusion Pack2026-09-22
00803622164569Perfusion PackPerfusion Pack2026-09-22
00803622164576Perfusion PackPerfusion Pack2026-09-22
00803622164583Perfusion PackPerfusion Pack2026-09-22
00803622164590Perfusion PackPerfusion Pack2026-09-22
00803622164606Perfusion PackPerfusion Pack2026-09-22
00803622164613Perfusion PackPerfusion Pack2026-09-22
00803622164668Perfusion PackPerfusion Pack2026-09-22
00803622164699Perfusion PackPerfusion Pack2026-09-22
00803622164750Perfusion PackPerfusion Pack2026-09-22
00803622164286Perfusion PackPerfusion Pack2026-08-25
00803622164316Perfusion PackPerfusion Pack2026-08-25
00803622164323Perfusion PackPerfusion Pack2026-08-25
00803622164040Perfusion PackPerfusion Pack2026-07-30
00803622163982Perfusion PackPerfusion Pack2026-07-17
00803622164071Perfusion PackPerfusion Pack2026-07-17
00803622164118Perfusion PackPerfusion Pack2026-07-17
00803622163623Perfusion PackPerfusion Pack2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479402178enableCV QuickDraw™ Plus Venous CannulaENABLECV INC.DWF2026-08-27
00824846013419NAMEDTRONIC, INC.DWF2026-08-23
00824846013501NAMEDTRONIC, INC.DWF2026-08-23
00824846012962NAMEDTRONIC, INC.DWF2026-08-14
00824846013099NAMEDTRONIC, INC.DWF2026-08-14
00824846005445NAMEDTRONIC, INC.DWF2026-07-30
00824846005469NAMEDTRONIC, INC.DWF2026-07-30
00824846005667NAMEDTRONIC, INC.DWF2026-07-30
00824846006022NAMEDTRONIC, INC.DWF2026-07-30
00824846007944NAMEDTRONIC, INC.DWF2026-07-30
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25