BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
FDA 510(k) K232651 · Boston Scientific Corporation
510(k) numberK232651
Submission
- Device name
- BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- Applicant
- Boston Scientific Corporation
St Paul, MN, US - Received
- August 31, 2023
- Decision date
- September 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
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| 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 |
| 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 |
| K220796 | IntellaMap Orion High Resolution Mapping CatheterDRF · Special | Boston Scientific Corporation | 06/10/2022SE |
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Questions and answers
When was BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter cleared by the FDA?
BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter (K232651) received a 510(k) decision of Substantially Equivalent on September 29, 2023, 29 days after the submission was received.
What is the product code of K232651?
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.