510(k) K050217
- Device
- FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING)
- Applicant
- BIOSENSE WEBSTER, INC.
- 510(k) number
- K050217
- Product code
- MTD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-03-30
- Date received
- 2005-01-31
- Regulation
- 870.1220
- Classification name
- Catheter, Intracardiac Mapping, High-density Array
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE R HOHMAN
- Address
- 3333 Diamond Canyon Rd. Diamond Bar CA US 91765 91765
FDA Registration Numbers#
- 9673241
- 3011610434
- 2183787
- 3016678045
- 2183744
- 1721686
- 3004450679
- 2182269
- 3009888344
- 2184149
- 2030404
- 3008093809
- 3016986313
- 3010273872
- 3013403214
- 2124215
- 3013627970
- 3019807891
- 1721676
- 2032112
- 3008452825
- 3011276773
- 3012179728
- 3038966633
- 3017060084
- 3005334138
- 3014279513
- 1928237
- 3013300026
- 1650907
- 3013581838
Source Documents#
Other 510(k) Records For Product Code MTD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261012 | OptiMap Catheter - 60mm (OPTI-CATH2-60) | Cortex, Inc. | 2026-04-23 |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | 2026-03-13 |
| K233433 | Sphere-9Dx Diagnostic Catheter (AFR-00009) | Medtronic | 2024-08-07 |
| K241372 | Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ | ABBOTT MEDICAL | 2024-07-09 |
| K231312 | PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID | Biosense Webster, Inc. | 2023-07-10 |
| K223666 | Ablacath™ Mapping Catheter | Ablacon, Inc. | 2023-03-17 |
| K230253 | OPTRELL™ Mapping Catheter with TRUEref™ Technology | Biosense Webster, Inc. | 2023-03-02 |
| K210766 | AcQMap 3D Imaging and Mapping Catheter, Model 900009 | Acutus Medical, Inc. | 2022-06-21 |
| K211438 | OPTRELL Mapping Catheter with TRUEref Technology | Biosense Webster, Inc. | 2022-03-18 |
| K201806 | Reprocessed PentaRay Nav eco High-Density Mapping Catheter | Sterilmed Inc. (Johnson and Johnson) | 2021-06-23 |
| K201341 | AcQMap 3D Imaging and Mapping Catheter | Acutus Medical, Inc. | 2020-09-15 |
| K200212 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled | Innovative Health, LLC | 2020-09-03 |
| K201750 | Pentaray Nav eco High-Density Mapping Catheter | Biosense Webster, Inc. | 2020-08-06 |
| K193237 | Carto Octaray Mapping Catheter with Trueref Technology | Biosense Webster, Inc. | 2020-07-31 |
| K172393 | Advisor HD Grid Mapping Catheter, Sensor Enabled | St. Jude Medical, Inc. | 2018-04-23 |
Legacy Summary#
summary
FDA Review#
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