JenaValve Production Limited

FDA Device Registration & Listing · Swillington Leeds, GB · Registration 3011894841

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011894841
FEI Number
3011894841
Entity Name
JenaValve Production Limited
City/State/Country
Swillington Leeds, GB
Establishment Address
Unit 9A Astley Way, Swillington Leeds LS26 8XT, GB
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
JenaValve Technology, Inc. (Owner Number: 10051384)
Owner / Operator Contact Address
4 Cromwell, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P250024

All Registered Proprietary Names

JenaValve Trilogy Transcatheter Heart Valve System JenaValve Trilogy Loading Tools JenaValve Trilogy Transcatheter Heart Valve System Trilogy Introducer Sheath Trilogy Transcatheter Heart Valve (THV) Trilogy Delivery Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2016-03-09
NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown Class 3 N/A 2026-03-19

Official Correspondent

Tonya Porter

US Agent Details

Tonya Porter Email: porter@jenavalve.com Phone: (909) 7174493

Related Public Records

Same Entity

JenaValve Technology, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012148004 JENAVALVE TECHNOLOGY, INC. Irvine, CA, US

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0491-2025 Abbott Medical 3
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Z-0492-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Z-0493-2025 Abbott Medical 3
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Z-0494-2025 Abbott Medical 3
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Z-0495-2025 Abbott Medical 3
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile

Similar Registrations

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2025587 Medtronic Heart Valves Division Santa Ana, CA, US
9617601 Medtronic Mexico S. de R.L. de CV Tijuana Baja California, MX
3005941719 Sterigenics Belgium Petit Rechain S.A. Verviers Liege, BE
3012148004 JENAVALVE TECHNOLOGY, INC. Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011894841. Last updated year: 2026. Please use registration number 3011894841 when referencing this establishment in official correspondence.
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