Ventricular Vent Catheter

GUDID 38033178019065

SORIN GROUP ITALIA SRL

Chamber-decompression cardiac catheter
Primary Device ID38033178019065
NIH Device Record Keyb8e2a1ed-e3cc-4670-b264-49379bc11228
Commercial Distribution StatusIn Commercial Distribution
Brand NameVentricular Vent Catheter
Version Model NumberVT-53218
Company DUNS442126587
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033178019064 [Primary]
GS138033178019065 [Package]
Contains: 08033178019064
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-19
Device Publish Date2026-02-11

On-Brand Devices [Ventricular Vent Catheter]

38033178019218VT-92116
38033178019201VT-89620
38033178019188VT-89616
38033178019171VT-89420
38033178019164VT-89418
38033178019157VT-89416
38033178019126VT-84413
38033178019119VT-84410
38033178019102VT-83116
38033178019096VT-63218
38033178019089VT-57320
38033178019072VT-57316
38033178019065VT-53218
38033178019058VT-46118
38033178019041VT-31212

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.