MultiCath, AcQRate Dx Fixed Curve Catheter
FDA 510(k) K201445 · Biotronik, Inc.
510(k) numberK201445
Submission
- Device name
- MultiCath, AcQRate Dx Fixed Curve Catheter
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- June 1, 2020
- Decision date
- September 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
Other 510(k)s with product code DRF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252794 | Vision-MR Diagnostic CatheterDRF · Traditional | Imricor Medical Systems, Inc. | 01/08/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | Boston Scientific Corporation | 11/01/2024SE |
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 09/29/2023SE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | Boston Scientific | 04/25/2023SE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
More from Shanghai Microport EP Medtech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261074 | Biomonitor IV (471155)MXD · Special | 05/01/2026SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | 04/04/2025SE |
| K242969 | Pantera Pro; Pantera LEOLOX · Special | 10/25/2024SE |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…DQY · Traditional | 09/12/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | 07/11/2024SE |
| K230375 | Biomonitor IVMXD · Traditional | 05/19/2023SE |
| K222065 | Passeo-35 Xeo Peripheral Dilatation CatheterLIT · Traditional | 02/16/2023SE |
| K221856 | BIOMONITOR IIIm, BIOMONITOR IIIMXD · Special | 07/27/2022SE |
| K222037 | Selectra Lead Implantation SystemDQY · Special | 07/19/2022SE |
| K214038 | Oscar Peripheral Multifunctional Catheter systemLIT · Traditional | 07/06/2022SE |
Questions and answers
When was MultiCath, AcQRate Dx Fixed Curve Catheter cleared by the FDA?
MultiCath, AcQRate Dx Fixed Curve Catheter (K201445) received a 510(k) decision of Substantially Equivalent on September 2, 2021, 458 days after the submission was received.
What is the product code of K201445?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.