FDA.reportPublic FDA data

Agilis™

Primary DI
05414734206112
Brand
Agilis™
Company
ST. JUDE MEDICAL, INC.
Model
G408318
Catalog number
G408318
Device description
NxT Steerable Introducer
Published
2015-03-06
Public version status
Update
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061363000
K241370000
K243493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061363000AGILIS NXT STEERABLE INTRODUCERSt Jude Medical2006-07-12DYB
K241370000Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)ABBOTT MEDICAL2024-06-13DYB
K243493000Agilis NxT Steerable Introducer Dual-ReachABBOTT MEDICAL2024-12-13DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734206112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734206112054147342061125414734206112

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular device introducer, steerableA sterile, steerable, tubular sheath designed for percutaneous placement in/near the cardiovascular system and through which other cardiovascular devices (e.g., cardiac/intravascular catheter, pacing lead) are subsequently inserted for positioning in blood vessels, heart chambers, or on epicardial surfaces. The distal tip is actuated via controls at the proximal end to accommodate manoeuvring in/around the heart. It may be fitted with a haemostasis valve (HV) to minimize blood loss during intervention [e.g., electrophysiology (EP)], a sideport for aspiration/infusion/blood sampling, have radiopaque markings, and may include a dedicated intraluminal dilator. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8.5French
Length61Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry, Keep away from sunlight, Protect from heat and radioactive sources
Special Storage Condition, Specify00STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.
Special Storage Condition, Specify00STORE IN COOL, DARK, DRY PLACE AWAY FROM RADIATION.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067033307Amplatzer™ Talisman™9-PFO-18189-PFO-18182021-09-29
05415067033314Amplatzer™ Talisman™9-PFO-25189-PFO-25182021-09-29
05415067033321Amplatzer™ Talisman™9-PFO-30259-PFO-30252021-09-29
05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
00811806011103Amplatzer™9-PDA-0039-PDA-0032014-09-08
00811806011110Amplatzer™9-PDA-0049-PDA-0042014-09-08
00811806011127Amplatzer™9-PDA-0059-PDA-0052014-09-08
00811806011134Amplatzer™9-PDA-0069-PDA-0062014-09-08
00811806011141Amplatzer™9-PDA-0079-PDA-0072014-09-08
00811806011172Amplatzer™9-PDA2-03-049-PDA2-03-042014-09-08
00811806011189Amplatzer™9-PDA2-03-069-PDA2-03-062014-09-19
00811806011202Amplatzer™9-PDA2-04-049-PDA2-04-042014-09-15
00811806011219Amplatzer™9-PDA2-04-069-PDA2-04-062014-09-15
00811806011233Amplatzer™9-PDA2-05-049-PDA2-05-042014-09-15
00811806011240Amplatzer™9-PDA2-05-069-PDA2-05-062014-09-15
00811806011257Amplatzer™9-PDA2-06-049-PDA2-06-042014-09-15
00811806011264Amplatzer™9-PDA2-06-069-PDA2-06-062014-09-15
05415067031570Navitor™NVTR-23NVTR-232023-01-16
05415067031587Navitor™NVTR-25NVTR-252023-01-16
05415067031594Navitor™NVTR-27NVTR-272023-01-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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