FDA.reportPublic FDA data

Trilogy Introducer Sheath

Primary DI
00850000898196
Brand
Trilogy Introducer Sheath
Company
Jenavalve Technology, Inc.
Model
TRILOGY-INT
Catalog number
TRILOGY-INT
Device description
Transfemoral Introducer Sheath System
Published
2026-03-25
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPTAortic Valve, Prosthesis, Percutaneously Delivered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPTAortic Valve, Prosthesis, Percutaneously DeliveredUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000898196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000898196008500008981968500008981960850000898196

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00These devices must be stored in a cool, dry place.

Contacts#

Phone, Email table
PhoneEmail
+1-866-588-8287CustomerSupport.US@jenavalve.com

Regulatory Flags#

DUNS number
827951620
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
true
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
00850000898134Trilogy Delivery CatheterTRILOGY-DC-STRILOGY-DC-S2026-03-25
00850000898141Trilogy Delivery CatheterTRILOGY-DC-MTRILOGY-DC-M2026-03-25
00850000898158Trilogy Delivery CatheterTRILOGY-DC-LTRILOGY-DC-L2026-03-25
00850000898165Trilogy Loading ToolsTRILOGY-LT-STRILOGY-LT-S2026-03-25
00850000898172Trilogy Loading ToolsTRILOGY-LT-MTRILOGY-LT-M2026-03-25
00850000898189Trilogy Loading ToolsTRILOGY-LT-LTRILOGY-LT-L2026-03-25
00850000898103Trilogy Transcatheter Heart ValveTRILOGY-THV-STRILOGY-THV-S2026-03-25
00850000898110Trilogy Transcatheter Heart ValveTRILOGY-THV-MTRILOGY-THV-M2026-03-25
00850000898127Trilogy Transcatheter Heart ValveTRILOGY-THV-LTRILOGY-THV-L2026-03-25
00850000898202Trilogy Transcatheter Heart ValveTRILOGY-THV-STRILOGY-THV-S2026-03-25
00850000898219Trilogy Transcatheter Heart ValveTRILOGY-THV-MTRILOGY-THV-M2026-03-25
00850000898226Trilogy Transcatheter Heart ValveTRILOGY-THV-LTRILOGY-THV-L2026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850000898103Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898110Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898127Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898134Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898141Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898158Trilogy Delivery CatheterJenavalve Technology, Inc.NPT2026-03-25
00850000898165Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898172Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898189Trilogy Loading ToolsJenavalve Technology, Inc.NPT2026-03-25
00850000898202Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898219Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00850000898226Trilogy Transcatheter Heart ValveJenavalve Technology, Inc.NPT2026-03-25
00763000942700Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-07
00763000942717Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-07
00763000942731Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-07
00763000942724Evolut™ FXMEDTRONIC COREVALVE LLCNPT2024-07-06
00763000716127Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
00763000716134Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
00763000716141Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
00763000716158Evolut™ FX+MEDTRONIC COREVALVE LLCNPT2024-05-03
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05415067045775Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045782Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045799Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067045805Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067048417Navitor™ST. JUDE MEDICAL, INC.NPT2023-09-29
05415067036650Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16
05415067036667Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16
05415067031570Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16
05415067031587Navitor™ST. JUDE MEDICAL, INC.NPT2023-01-16