ClearanceBrief
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)
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Top companies in NPT

Company510(k)sRecalls
Edwards Lifesciences, LLC010
Boston Scientific Corporation09
Medtronic Heart Valves Division06
Abbott Medical05
Jenavalve Technology Inc.03
Medtronic Cardiovascular Surgery-the Heart Valve Division02
CryoLife, Inc.01
DateFirm and productCodeLinked 510(k)
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Open, Classified
NPTNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Open, Classified
NPTNone listed
Oct 9, 2026Jenavalve Technology Inc.
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Open, Classified
NPTNone listed
Nov 20, 2024Abbott Medical
Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Open, Classified
NPTNone listed
Nov 20, 2024Abbott Medical
Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Open, Classified
NPTNone listed
Nov 20, 2024Abbott Medical
Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Open, Classified
NPTNone listed
Nov 20, 2024Abbott Medical
Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Open, Classified
NPTNone listed
Nov 20, 2024Abbott Medical
Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Open, Classified
NPTNone listed
Jun 11, 2021Medtronic Heart Valves Division
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US;
Open, Classified
NPTNone listed
Jun 11, 2021Medtronic Heart Valves Division
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16;
Open, Classified
NPTNone listed
Jun 11, 2021Medtronic Heart Valves Division
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N;
Open, Classified
NPTNone listed
Jan 9, 2021Boston 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
NPTNone listed
Jan 9, 2021Boston 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
NPTNone listed
Jan 9, 2021Boston 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
NPTNone listed
Jan 9, 2021Boston 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
NPTNone listed
Jan 9, 2021Boston 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
NPTNone listed
Jan 9, 2021Boston Scientific Corporation
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 23mm, sterile, REF H749LVSUS230, GTIN 08714729960904
Terminated
NPTNone listed
Oct 23, 2020Medtronic 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
NPTNone listed
Oct 23, 2020Medtronic 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
NPTNone listed
Oct 23, 2020Medtronic 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
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Terminated
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
Terminated
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
Terminated
NPTNone listed
Aug 21, 2019Edwards Lifesciences, LLC
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
Terminated
NPTNone listed
Jan 22, 2019Edwards Lifesciences, LLC
Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LD
Terminated
NPTNone listed
Jun 11, 2018Edwards Lifesciences, LLC
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
Terminated
NPTNone listed
Jan 10, 2018Edwards 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
NPTNone listed
Aug 16, 2016Medtronic 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
NPTNone listed
Aug 5, 2015Medtronic 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
NPTNone listed
Jan 13, 2015Boston 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
NPTNone listed
Jan 13, 2015Boston 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
NPTNone listed
Jan 13, 2015Boston 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
NPTNone listed
Feb 12, 2014CryoLife, 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
NPTNone listed
Feb 3, 2014Edwards Lifesciences, LLC
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Terminated
NPTNone listed
Apr 17, 2013Edwards 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
NPTNone listed
Apr 17, 2013Edwards 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
NPTNone listed

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