FDA.reportPublic FDA data

AngioVac

Primary DI
15051684019873
Brand
AngioVac
Company
NAVILYST MEDICAL, INC.
Model
H965252810
Device description
AngioVac Circuit
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142607000AngioVac CircuitAngiodynamics2014-12-11DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965252810PrimaryHIBCC0
15051684019873SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401987315051684019873

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
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
H74904490200NAMIC04490202016-09-20
H965457480AngioDynamics457482016-09-20
H965457490AngioDynamics457492016-09-20
H965457500AngioDynamics457502016-09-20
H965457510AngioDynamics457512016-09-20
H965457520AngioDynamics457522016-09-20
H965457530AngioDynamics457532016-09-20
H965457540AngioDynamics457542016-09-20
H965457550AngioDynamics457552016-09-20
H965457560AngioDynamics457562016-09-20
H965457570AngioDynamics457572016-09-20
H965457580AngioDynamics457582016-09-20
H965457590AngioDynamics457592016-09-20
H965457600AngioDynamics457602016-09-20
H965457610AngioDynamics457612016-09-20
H965457620AngioDynamics457622016-09-20
H965457630AngioDynamics457632016-09-20
H965457640AngioDynamics457642016-09-20
H965457650AngioDynamics457652016-09-20
H965457660AngioDynamics457662016-09-20

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00803622164934Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
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