FDA.reportPublic FDA data

Agilis™ NxT Steerable Introducer Dual-Reach™

Primary DI
05415067050182
Brand
Agilis™ NxT Steerable Introducer Dual-Reach™
Company
ST. JUDE MEDICAL, INC.
Model
SI-1371-S
Catalog number
SI-1371-S
Device description
Steerable Introducer
Published
2024-08-15
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
K241370000
K243493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
05415067050182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067050182054150670501825415067050182

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge13French
Length71Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Special Storage Condition, Specify00Excursions permitted from -20°C to 50°C, and 10%-90% store at room temperature 10°C to 25°C, Keep dry, keep away from sunlight, protect from heat and radioactive sources
Special Storage Condition, Specify00Store at 10-25°C. Excursions permitted from -20-50°C. Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

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

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Primary DI, Brand, Model table
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05415067033345Amplatzer™ Talisman™9-PFO-35259-PFO-35252021-09-29
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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
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