baylismedical.comPowerWire® 14 Radiofrequency Guidewire Kit
Baylis Medical Technologies, Inc.
Baylis Medical Technologies Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3020689212 | 3020689212 | Baylis Medical Technologies Inc. | 1 | Y | 2026-01-01 | 11320 State Route 9 Champlain NY US 12919 |
| 3020968442 | 3020968442 | BAYLIS MEDICAL TECHNOLOGIES INC. | 1 | N | 2026-01-01 | 2645 Matheson Blvd E Mississauga Ontario CA L4W5S4 |
| 3004572127 | 3004572127 | BAYLIS MEDICAL COMPANY INC. | 1 | Y | 2020-04-25 | 1320 ROUTE 9 CHAMPLAIN NY US 12919 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00685447000938 | RFP-100A Connector Cable - RFX-BAY-OTW-12-SU | 5144889801 | info@baylismedical.com |
| 00685447003298 | VersaCross RF Wire - 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use) | 5144889801 | info@baylismedical.com |
| 00685447003304 | VersaCross RF Wire - 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use) | 5144889801 | info@baylismedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 296315 | 1157505093 | K990284 | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE | DXF | 2001-02-01 |
| 296315 | 1811811242 | K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | PDU | 2025-09-11 |
| 296315 | 2070779572 | K232562 | PowerWire Radiofrequency Guidewire Kit | PDU | 2024-02-28 |
| 296315 | 1486569988 | K230571 | RFP-100A Connector Cable (Single Use) | DSA | 2023-05-30 |
| 296315 | 1763865561 | K151951 | Destino Reach | DYB | 2015-09-22 |
| 296315 | 1738855402 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | 2014-04-17 |
| 296315 | 1358736166 | K132374 | BAYLIS MEDICAL RF PERFORATION PROBE V2.0 | GEI | 2013-08-30 |
| 296315 | 1144825111 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-06-29 |
| 296315 | 1943015122 | K101615 | POWERWIRE RADIOFREQUENCY GUIDEWIRE | PDU | 2010-07-28 |
| 296315 | 1909477534 | K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 | DQX | 2002-03-07 |
| 296315 | 1054625968 | K010265 | BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265 | GEI | 2001-04-09 |
| 296315 | 1107392518 | ||||
| 296315 | 1264096375 | ||||
| 296315 | 1345575744 | ||||
| 296315 | 1534218064 | ||||
| 296315 | 2016379000 |
Product Codes Associated With Registrations#
PMN#
VersaCross? RF Wire
Baylis Medical Company
VersaCross Connect? Transseptal Dilator
Baylis Medical Company, Inc.
PowerWire Radiofrequency Guidewire Kit
Baylis Medical Technologies, Inc.
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Baylis Medical Company, Inc.
VersaCross Connect? Transseptal Dilator
Baylis Medical Company, Inc.
RFP-100A Connector Cable (Single Use)
Baylis Medical Technologies, Inc.
ProTrack Pigtail Wire
Baylis Medical Company, Inc.
Mechanical Guidewire
Baylis Medical Company, Inc.
Epicardial Access System
Baylis Medical Company Inc.
VersaCross Connect Transseptal Dilator
Baylis Medical Company, Inc.
ExpanSure Large Access Transseptal Dilator
Baylis Medical Company Inc.
Epicardial Access System
Baylis Medical Company Inc.
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
Baylis Medical Company Inc.
Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
Baylis Medical Company Inc.
VersaCross Transseptal Sheath
Baylis Medical Company Inc.
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
Baylis Medical Company Inc.
ExpanSure Transseptal Dilation System
Baylis Medical Company Inc.
Polaris RF Ablation System
Baylis Medical Company Inc.
OsteoCool V-3 RF Ablation System
Baylis Medical Company Inc.
PORTAGE System
Baylis Medical Company Inc.
OsteoCool V-3 RF Ablation System
BAYLIS MEDICAL COMPANY INC.
Nexus Suture
BAYLIS MEDICAL COMPANY INC.
ProTrack RF Anchor Wire
BAYLIS MEDICAL COMPANY INC.
OsteoCool V-2 RF Ablation System
BAYLIS MEDICAL COMPANY INC.
BAYLIS MEDICAL RF PERFORATION PROBE V2.0
BAYLIS MEDICAL COMPANY INC.
SUREFLEX STEERABLE GUIDING SHEATH KIT
BAYLIS MEDICAL CO., INC.
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
BAYLIS MEDICAL COMPANY INC.
OSTEOCOOL (TM) RF ABLATION SYSTEM
BAYLIS MEDICAL CO., INC.
TORFLEX TRANSSEPTAL GUIDING SHEATH
BAYLIS MEDICAL CO., INC.
INDISCAL DIGITAL MANOMETER
BAYLIS MEDICAL CO., INC.
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
BAYLIS MEDICAL CO., INC.
POWERWIRE RADIOFREQUENCY GUIDEWIRE
BAYLIS MEDICAL CO., INC.
LEV-OR DILATION CATHETER OTW
BAYLIS MEDICAL CO., INC.
INDISCAL ASPIRATION DEVICE AND ACCESSORIES
BAYLIS MEDICAL CO., INC.
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
BAYLIS MEDICAL CO., INC.
NRG TRANSSEPTAL NEEDLE
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD
BAYLIS MEDICAL CO., INC.
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
BAYLIS MEDICAL CO., INC.
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU
BAYLIS MEDICAL CO., INC.
GUDID#
PowerWire 14 Radiofrequency Guidewire Kit - PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
2025-12-04
PowerWire 14 Radiofrequency Guidewire Kit - PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
2025-12-04
PowerWire 14 Radiofrequency Guidewire Kit - PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
2025-12-04
PowerWire 14 Radiofrequency Guidewire Kit - PowerWire 14 Radiofrequency Guidewire, Baylis Connector Cable
2025-12-04
RFP-100A Connector Cable - RFX-BAY-OTW-12-SU
2016-08-15
VersaCross RF Wire - 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use)
2019-05-01
VersaCross RF Wire - 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use)
2019-05-01
VersaCross RF Wire - 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use)
2019-05-01
VersaCross RF Wire - 1 x VersaCross RF Wire; 1 x Connector Cable (Single Use)
2019-05-01
VersaCross Transseptal Sheath - 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
2019-06-26
VersaCross Transseptal Sheath - 1 x VersaCross Transseptal Sheath; 1 x VersaCross Transseptal Dilator; 1 x J-Tip Guidewire
2019-06-26
VersaCross Steerable Sheath - 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
2021-04-08
VersaCross Steerable Sheath - 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
2021-04-08
VersaCross Steerable Sheath - 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
2021-04-08
VersaCross Steerable Sheath - 1 x VersaCross Steerable Sheath; 1 x J-Tip Guidewire; 1 x VersaCross Transseptal Dilator
2021-04-08
VersaCross Large Access Transseptal Dilator - 1 x VersaCross Large Access Transseptal Dilator; 1 x J-Tip Guidewire
2021-06-10
VersaCross Large Access Transseptal Dilator - 1 x VersaCross Large Access Transseptal Dilator; 1 x J-Tip Guidewire
2021-06-10
VersaCross Large Access Transseptal Dilator - 1 x VersaCross Large Access Transseptal Dilator; 1 x J-Tip Guidewire
2021-06-10
VersaCross Large Access Transseptal Dilator - 1 x VersaCross Large Access Transseptal Dilator; 1 x J-Tip Guidewire
2021-06-10
VersaCross Connect Transseptal Dilator - 1 x VersaCross Connect Transseptal Dilator; 1 x J-Tip Guidewire (Single Use)
2022-05-19
VersaCross Connect Transseptal Dilator - 1 x VersaCross Connect Transseptal Dilator; 1 x J-Tip Guidewire (Single Use)
2022-05-19
VersaCross Connect Transseptal Dilator - 1 x VersaCross Connect Transseptal Dilator (Single Use)
2023-08-15
Adult Dispersive Electrode - Suggested weight: >15kg
2017-02-03
VersaCross Steerable Access Solution - 1 x VersaCross Steerable Sheath (including 1 x Dilator and 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use)); 1 x Dispersive Electrode
2022-05-09
VersaCross Access Solution - 1 x VersaCross Transseptal Sheath (including 1 x J-tip Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))
2022-07-08
PowerWire Pulse RF Guidewire Kit - PowerWire Pulse RF Guidewire; RFP-100A Connector Cable
2024-09-27
PowerWire Pulse RF Guidewire Kit - PowerWire Pulse RF Guidewire; RFP-100A Connector Cable
2024-09-27
PowerWire Pulse RF Guidewire Kit - PowerWire Pulse RF Guidewire; RFP-100A Connector Cable
2024-09-27
AnchorKnot Tissue Approximation Kit - AnchorKnot Suture Passer (2-0); AnchorKnot Knot Pusher (2-0); AnchorKnot Suture Cutter (2-0)
2022-11-16
AnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0) - PSZ-400-311
2022-11-16
AnchorKnot Suture Passer (2-0) - PSZ-400-305
2022-11-16
AnchorKnot Suture - Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Cartridge, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Cartridge, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Reel, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Reel, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16
AnchorKnot Suture - Cut Length, White/Blue Co-braid, Polyethylene/Polypropylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
2022-11-16