BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
FDA 510(k) K171514 · Biotronik, Inc.
510(k) numberK171514
Submission
- Device name
- BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- May 24, 2017
- Decision date
- June 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code MXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262735 | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)MXD · Special | Medtronic, Inc. | 08/28/2026SE |
| K261074 | Biomonitor IV (471155)MXD · Special | Biotronik, Inc. | 05/01/2026SE |
| K253516 | Assert-IQ (DM5100)MXD · Special | Abbott Medical | 12/18/2025SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | Abbott | 09/17/2025SE |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)MXD · Special | Boston Scientific Corporation | 09/12/2025SE |
| K240693 | LINQ II Insertable Cardiac Monitor (ICM)MXD · Special | Medtronic, Inc. | 03/28/2024SE |
| K233562 | LINQ II Insertable Cardiac MonitorMXD · Special | Medtronic, Inc. | 12/06/2023SE |
| K233320 | LINQ II Insertable Cardiac Monitor (LNQ22)MXD · Special | Medtronic, Inc. | 10/31/2023SE |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312)MXD · Traditional | Boston Scientific Corp | 08/19/2023SE |
| K230375 | Biomonitor IVMXD · Traditional | Biotronik, Inc. | 05/19/2023SE |
More from Biotronik, Inc.
| 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 BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set cleared by the FDA?
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set (K171514) received a 510(k) decision of Substantially Equivalent on June 29, 2017, 36 days after the submission was received.
What is the product code of K171514?
The FDA product code is MXD – Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection), a Class II (moderate risk) device regulated under 21 CFR 870.1025.