Product code NPT ยท Class 3
Aortic Valve, Prosthesis, Percutaneously Delivered
0510(k)s in 12 months (0 all time)
3recalls in 12 months (36 all time)
0recalls that name a 510(k)
Top companies in NPT
| Company | 510(k)s | Recalls |
|---|---|---|
| Edwards Lifesciences, LLC | 0 | 10 |
| Boston Scientific Corporation | 0 | 9 |
| Medtronic Heart Valves Division | 0 | 6 |
| Abbott Medical | 0 | 5 |
| Jenavalve Technology Inc. | 0 | 3 |
| Medtronic Cardiovascular Surgery-the Heart Valve Division | 0 | 2 |
| CryoLife, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 27MM
REF: TRILOGY-DC-L Open, Classified |
NPT | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 25MM
REF: TRILOGY-DC-M Open, Classified |
NPT | None listed |
| Oct 9, 2026 | Jenavalve Technology Inc. JenaValve Trilogy Delivery Catheter, Size 23MM
REF: TRILOGY-DC-S Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile Open, Classified |
NPT | None listed |
| Nov 20, 2024 | Abbott Medical Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile Open, Classified |
NPT | None listed |
| Jun 11, 2021 | Medtronic Heart Valves Division CoreValve Evolut PRO PLUS Delivery Catheter System,
REF:
D-EVPROP2329US;
D-EVPROP34US; Open, Classified |
NPT | None listed |
| Jun 11, 2021 | Medtronic Heart Valves Division CoreValve Evolut PRO Delivery Catheter System,
REF:
ENVPRO-14;
ENVPRO-16; Open, Classified |
NPT | None listed |
| Jun 11, 2021 | Medtronic Heart Valves Division CoreValve Evolut R Delivery Catheter System,
REF:
ENVEOR-L;
ENVEOR-N; Open, Classified |
NPT | None listed |
| Jan 9, 2021 | Boston Scientific Corporation Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Irel Terminated |
NPT | None listed |
| Jan 9, 2021 | Boston Scientific Corporation Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVS250, GTIN 08714729940821, Made in Ireland, Ballybrit Business Park, Galway, Irel Terminated |
NPT | None listed |
| Jan 9, 2021 | Boston Scientific Corporation Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVS230, GTIN 08714729940814, Made in Ireland, Ballybrit Business Park, Galway, Irel Terminated |
NPT | None listed |
| Jan 9, 2021 | Boston Scientific Corporation Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVSUS270, GTIN 08714729960928, Made in Ireland, Ballybrit Business Park, Galway, Ir Terminated |
NPT | None listed |
| Jan 9, 2021 | Boston Scientific Corporation Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ir Terminated |
NPT | None listed |
| Jan 9, 2021 | Boston Scientific Corporation Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904 Terminated |
NPT | None listed |
| Oct 23, 2020 | Medtronic Heart Valves Division Evolut (TM) PRO+ System. With the following model numbers:
a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US;
b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US Terminated |
NPT | None listed |
| Oct 23, 2020 | Medtronic Heart Valves Division Evolut (TM) PRO System. With the following model numbers:
a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EV Terminated |
NPT | None listed |
| Oct 23, 2020 | Medtronic Heart Valves Division Evolut (TM) R System. With the following model numbers:
a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLU Terminated |
NPT | None listed |
| Aug 21, 2019 | Edwards Lifesciences, LLC Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29
UDI:00690103201260 Terminated |
NPT | None listed |
| Aug 21, 2019 | Edwards Lifesciences, LLC Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26
UDI:00690103201253 Terminated |
NPT | None listed |
| Aug 21, 2019 | Edwards Lifesciences, LLC Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23
UDI:00690103201246 Terminated |
NPT | None listed |
| Aug 21, 2019 | Edwards Lifesciences, LLC Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20
UDI:00690103201239 Terminated |
NPT | None listed |
| Jan 22, 2019 | Edwards Lifesciences, LLC Edward Lifesciences, Edwards Commander Delivery System:
Model Number UDI Number
9600LDS20A (US) 00690103193930
9600LDS20J 00690103194852
9600LDS23A (US) 00690103193947
9600LDS23J 00690103194869
9600LD Terminated |
NPT | None listed |
| Jun 11, 2018 | Edwards Lifesciences, LLC Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm Terminated |
NPT | None listed |
| Jan 10, 2018 | Edwards Lifesciences, LLC Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A
Product Usage:
The Edwards Certitude Delivery System is used for delivery of the Edwards SA Terminated |
NPT | None listed |
| Aug 16, 2016 | Medtronic Cardiovascular Surgery-the Heart Valve Division Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US.
Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery a Terminated |
NPT | None listed |
| Aug 5, 2015 | Medtronic Cardiovascular Surgery-the Heart Valve Division EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C.
Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system. Terminated |
NPT | None listed |
| Jan 13, 2015 | Boston Scientific Corporation Lotus TAVR 27mm,
Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;
Sterile
Material number H749LTV270, Catalog Number LTV27;
Product Usage: The Lotus Valve System is intended to im Terminated |
NPT | None listed |
| Jan 13, 2015 | Boston Scientific Corporation Lotus TAVR 25mm,
Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;
Sterile
Material number H749LTV250, Catalog Number LTV25;
Product Usage: The Lotus Valve System is intended to im Terminated |
NPT | None listed |
| Jan 13, 2015 | Boston Scientific Corporation Lotus TAVR 23mm,
Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;
Sterile
Material number H749LTV230, Catalog Number LTV23;
Product Usage: The Lotus Valve System is intended to i Terminated |
NPT | None listed |
| Feb 12, 2014 | CryoLife, Inc. On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use.
Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position Terminated |
NPT | None listed |
| Feb 3, 2014 | Edwards Lifesciences, LLC Crimper Model 9100CR26
The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation. Terminated |
NPT | None listed |
| Apr 17, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Crimpers, Model 9100CR26.
The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. Terminated |
NPT | None listed |
| Apr 17, 2013 | Edwards Lifesciences, LLC Edwards Lifesciences Crimpers, Model 9100CR23.
The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. Terminated |
NPT | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.