510(k) K160335
- Device
- Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
- Applicant
- St. Jude Medical
- 510(k) number
- K160335
- Product code
- DRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-13
- Date received
- 2016-02-08
- Regulation
- 870.1220
- Classification name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tamara Stanczak
- Address
- 5050 Nathan Ln. Plymouth MN US 55442 55442
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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