FDA.reportPublic FDA data

Trilogy Delivery Catheter

Primary DI
00850000898141
Brand
Trilogy Delivery Catheter
Company
Jenavalve Technology, Inc.
Model
TRILOGY-DC-M
Catalog number
TRILOGY-DC-M
Device description
Transfemoral Delivery Catheter, Size 25MM
Published
2026-03-25
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
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
00850000898141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000898141008500008981418500008981410850000898141

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
Device Size Text, specify0

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850000898134Trilogy Delivery CatheterTRILOGY-DC-STRILOGY-DC-S2026-03-25
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
00850000898196Trilogy Introducer SheathTRILOGY-INTTRILOGY-INT2026-03-25
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
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
00850000898196Trilogy Introducer SheathJenavalve 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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