510(k) K151622
- Device
- St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter With Lumen, Response Electrophysiology Catheter And SJM Epicardial Catheter System, Supreme Elec
- Applicant
- St. Jude Medical
- 510(k) number
- K151622
- Product code
- DRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-15
- Date received
- 2015-06-16
- Regulation
- 870.1220
- Classification name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Maria Obreztchikova
- Address
- 14901 Deveau Pl. Minnetonka MN US 55345 55345
FDA Registration Numbers#
- 3025341484
- 1061124
- 3012179728
- 2528981
- 2024311
- 3008093809
- 2031044
- 2182208
- 1721676
- 3003678543
- 3013403214
- 3016678045
- 1028232
- 3018258443
- 3014368660
- 2184149
- 3008824097
- 3009337690
- 3009243923
- 3010200163
- 3011024991
- 2135338
- 3009254201
- 3006634485
- 3009393076
- 2184009
- 2182269
- 3027305778
- 3019751610
- 2032112
- 1000121056
- 1018233
- 3005402529
- 3010532612
- 1450662
- 1928237
- 2126666
- 1721686
- 3013581838
- 2124215
- 8043831
- 3011610434
- 3027815
- 3013300026
- 1650907
- 3032391
- 1225687
- 9680001
- 3008497357
- 3010273872
- 2648623
- 3013162291
- 3019807891
- 3010705768
- 2028523
- 9610139
- 3011276773
- 9673241
- 9617601
- 3015859709
- 9681260
- 3007616088
- 3008452825
- 2024024
- 9680794
- 3015537323
- 3017060084
- 3004859241
- 1313046
- 2649622
- 3009888344
- 1317547
- 3013400708
- 2029275
- 3006891611
- 1927197
- 1643817
- 2030404
- 3003289723
- 2030624
Source Documents#
Other 510(k) Records For Product Code DRF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252794 | Vision-MR™ Diagnostic Catheter | Imricor Medical Systems, Inc. | 2026-01-08 |
| K250590 | MAGiC Sweep™ EP Mapping Catheter | Stereotaxis, Inc. | 2025-07-23 |
| K250310 | VIKING™ Fixed Curve Diagnostic Catheter | Boston Scientific Corporation | 2025-06-27 |
| K240366 | EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2024-11-01 |
| K233900 | Nordica PV Cryo Mapping Catheter | Synaptic Medical Corporation | 2024-09-06 |
| K233397 | Cosine-10TM Diagnostic Catheter | Medtronic, Inc. | 2023-12-02 |
| K233207 | Polaris X™ Unidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-10-27 |
| K232651 | BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter | Boston Scientific Corporation | 2023-09-29 |
| K230503 | Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable | Boston Scientific | 2023-04-25 |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter | Shanghai Microport EP Medtech Co., Ltd. | 2022-12-30 |
| K220796 | IntellaMap Orion High Resolution Mapping Catheter | Boston Scientific Corporation | 2022-06-10 |
| K203793 | RithmID-SD Steerable Diagnostic Electrophysiology Catheter | Synaptic Medical Corporation | 2022-02-14 |
| K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | CathRx, Ltd. | 2022-02-10 |
| K211219 | LASSOSTAR NAV Circular Mapping Catheter | Biosense Webster, Inc. | 2022-01-26 |
| K212593 | ViaCath, AcQRate Dx Steerable Catheter | Biotronick, Inc. | 2021-10-15 |
Legacy Summary#
summary
FDA Review#
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