FDA.reportPublic FDA data

Attain™

Primary DI
00763000227982
Brand
Attain™
Company
MEDTRONIC, INC.
Model
6215
Device description
CATH 6215 VENOGRAM BALLOON ATTAIN EIFU
Published
2020-07-04
Public version status
New
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
DYGCATHETER, FLOW DIRECTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012225000ATTAIN 6215 VENOGRAM BALLOON CATHETERMedtronic Vascular2001-08-28DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000227982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000227982007630002279827630002279820763000227982

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522270Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
00885403522348SWAN-GANZ CCOMBO VBecton, Dickinson And CompanyDYG2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDYG2026-05-30
00690103218282SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103000382SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
50690103218287SWAN-GANZ VIPEdwards Lifesciences LLCDYG2026-03-16
50690103218638SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDYG2026-03-16
00690103217094Swan-GanzEdwards Lifesciences LLCDYG2025-07-11
00690103219371SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219289SWAN GANZEdwards Lifesciences LLCDYG2024-08-30
00690103219388SWAN-GANZEdwards Lifesciences LLCDYG2024-08-05
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10801902206432ARROWTELEFLEX INCORPORATEDDYG2022-10-20
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20801902206453ARROWTELEFLEX INCORPORATEDDYG2022-10-20
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10801902208979ARROWTELEFLEX INCORPORATEDDYG2022-03-18
20801902208976ARROWTELEFLEX INCORPORATEDDYG2022-03-18
10801902206647ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206654ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206661ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206678ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206715ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206722ARROWTELEFLEX INCORPORATEDDYG2022-03-14