Home / 510(k) Clearances / K181864

510(k) K181864

Polaris RF Ablation System by Baylis Medical Company, Inc. — Product Code GXD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2019
Date Received
July 12, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Baylis Medical Company, Inc.

  • K251325 — VersaCross Connect™ Transseptal Dilator (May 29, 2025)
  • K241720 — VersaCross Connect™ Transseptal Dilator (July 12, 2024)
  • K231227 — SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath (December 20, 2023)
  • K233647 — VersaCross Connect™ Transseptal Dilator (December 14, 2023)
  • K213898 — ProTrack Pigtail Wire (March 1, 2023)
  • K221351 — Mechanical Guidewire (December 19, 2022)
  • K213582 — Epicardial Access System (June 30, 2022)
  • K220414 — VersaCross Connect Transseptal Dilator (May 9, 2022)
  • K201288 — ExpanSure Large Access Transseptal Dilator (June 12, 2020)
  • K191546 — Epicardial Access System (August 2, 2019)

Other clearances for product code GXD

  • K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (August 7, 2025)
  • K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADV (August 14, 2024)
  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • K220122 — APEX 6 (March 15, 2023)
  • K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS (January 21, 2022)
  • K201610 — IonicRF Generator (October 21, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)
  • K170242 — MultiGen™ 2 RF Generator System (May 25, 2017)