Product code NKE ยท Class 3
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
0510(k)s in 12 months (0 all time)
1recalls in 12 months (28 all time)
0recalls that name a 510(k)
Top companies in NKE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2026 | Boston Scientific Corporation Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:
1. VALITUDE CRT-P EL, Model Number U125;
2. VALITUDE CRT-P EL MRI, Model Number U128;
3. VISIONIST CRT-P EL, Model Number U225; Open, Classified |
NKE | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number U228, VISIONIST CRT-P EL MRI Open, Classified |
NKE | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number U226, VISIONIST CRT-P EL Open, Classified |
NKE | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number U225 VISIONIST CRT-P EL Open, Classified |
NKE | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number U128, VALITUDE CRT-P EL MRI Open, Classified |
NKE | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number U125, VALITUDE CRT-P EL Open, Classified |
NKE | None listed |
| Jan 10, 2025 | Boston Scientific Corporation VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228) Open, Classified |
NKE | None listed |
| Jan 10, 2025 | Boston Scientific Corporation VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128) Open, Classified |
NKE | None listed |
| Jul 13, 2021 | Boston Scientific Corporation INLIVEN CRT-P, Model Numbers:
a) V284
b) V285
c) W274
d) W275 (added 7/15/2021) Open, Classified |
NKE | None listed |
| Jul 13, 2021 | Boston Scientific Corporation INTUA CRT-P, Model Numbers:
a) V272
b) V273
c) W273 Open, Classified |
NKE | None listed |
| Jul 13, 2021 | Boston Scientific Corporation INVIVE CRT-P, Model Numbers:
a) V172
b) V173
c) V182
d) V183
e) W172
f) W173 Open, Classified |
NKE | None listed |
| Jul 2, 2021 | Boston Scientific Corporation VISIONIST CRT-P pacemaker, Models:
a) U225
b) U226
c) U228 Open, Classified |
NKE | None listed |
| Jul 2, 2021 | Boston Scientific Corporation VALITUDE CRT-P pacemaker, Models:
a) U125
b) U128 Open, Classified |
NKE | None listed |
| Apr 6, 2021 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) CRT-P Quad Models (CRT-Ps):
a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04
b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05
c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06.
implantabl Open, Classified |
NKE | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Percepta Quad CRT-P MRI SureScan, REF W4TR04
Product Usage:
The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the pa Terminated |
NKE | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Percepta CRT-P MRI SureScan, REF W1TR04
Product Usage:
The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient Terminated |
NKE | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Percepta Quad CRT-P MRI SureScan, REF W4TR01
Product Usage:
The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the pa Terminated |
NKE | None listed |
| Jul 10, 2018 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Percepta CRT-P MRI SureScan, REF W1TR01
Product Usage:
The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient Terminated |
NKE | None listed |
| Dec 7, 2017 | Boston Scientific Corporation VISIONIST X4 CRT-P Pacemaker Open, Classified |
NKE | None listed |
| Dec 7, 2017 | Boston Scientific Corporation VISIONIST CRT-P Pacemaker Open, Classified |
NKE | None listed |
| Dec 7, 2017 | Boston Scientific Corporation VALITUDE X4 CRT-P Pacemaker Open, Classified |
NKE | None listed |
| Dec 7, 2017 | Boston Scientific Corporation VALITUDE CRT-P Pacemaker Open, Classified |
NKE | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply Terminated |
NKE | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that Terminated |
NKE | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CR Terminated |
NKE | None listed |
| Nov 27, 2015 | Medtronic Inc. Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. Terminated |
NKE | None listed |
| Jun 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO.
Dual chamber and atrial tracking modes are indicated for patients who may benefi Terminated |
NKE | None listed |
| Sep 28, 2006 | Boston Scientific CRM Corp CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENE Terminated |
NKE | None listed |
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