Home / 510(k) Clearances / K212593

510(k) K212593

ViaCath, AcQRate Dx Steerable Catheter by Biotronick, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2021
Date Received
August 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances for product code DRF

  • K252794 — Vision-MR™ Diagnostic Catheter (January 8, 2026)
  • K250590 — MAGiC Sweep™ EP Mapping Catheter (July 23, 2025)
  • K250310 — VIKING™ Fixed Curve Diagnostic Catheter (June 27, 2025)
  • K240366 — EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional (November 1, 2024)
  • K233900 — Nordica PV Cryo Mapping Catheter (September 6, 2024)
  • K233397 — Cosine-10TM Diagnostic Catheter (December 2, 2023)
  • K233207 — Polaris X™ Unidirectional Steerable Diagnostic Catheter (October 27, 2023)
  • K232651 — BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (September 29, 2023)
  • K230503 — Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable (April 25, 2023)
  • K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter (December 30, 2022)