FDA.report

Mariner

Primary DI
15051684016162
Brand
Mariner
Company
ANGIODYNAMICS, INC.
Model
11709227
Device description
Mariner Angiographic Catheter, Sos Omni Selective (1), Non-Braided
Published
2019-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions

SubmissionSupplement
K173762000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K173762000AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersAngioDynamics, Inc.2018-07-18DQO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H787117092275PackageHIBCC5In Commercial Distribution
H787117092270PrimaryHIBCC0
15051684016162SecondaryGS10

GMDN Terms

TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge4French

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags

DUNS number
079105071
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

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25051684029985BioFloH96546032046-0322025-03-18
25051684029992BioFloH96546033046-0332025-03-18
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25051684030011BioFloH96546043046-0432025-03-18
25051684009659Soft-VuH787107320020107320022025-03-03
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15051684016865BioFlo VortexCT50STBAVI2024-11-19
15051684019019ADx Guidewire8101382602024-11-11
H7878101351500ADx8101351502021-01-06
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H7878105251500ADx8105251502021-01-13
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H7878105321500ADx8105321502021-01-06
H7878105350800ADx8105350802021-01-06
H7878105351500ADx8105351502020-11-25
H7878105351800ADx8105351802020-11-25
H7878105352600ADx8105352602020-11-25

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