510(k) K211662
- Device
- Reprocessed IntellaMap Orion High Resolution Mapping Catheter
- Applicant
- Innovative Health, LLC.
- 510(k) number
- K211662
- Product code
- DRF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-18
- Date received
- 2021-06-01
- 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
- Rick Ferreira
- Address
- 1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257
FDA Registration Numbers#
- 3011276773
- 2032112
- 3011610434
- 3011024991
- 3009888344
- 2183744
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#
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FDA Review#
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