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Baylis Médicale Cie Inc

US

Last updated May 24, 2026

What Baylis Médicale Cie Inc makes

Baylis Médicale Cie Inc manufactures single-use and reusable devices for cardiac and vascular procedures, including transseptal access sets (dilators and sheaths), steerable guiding sheaths, and cardiac mapping catheters. Their product line also covers vascular guide-catheters and electrical connection cables designed for medical device integration. The company produces electrosurgical electrodes for endoscopic procedures, primarily monopolar and single-use.

All listed devices fall under FDA Class II regulation and are included in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, with its products authorised for commercial distribution through FDA compliance pathways.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
5144889801
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
249225954

Catalogue (1220)

Page 6 of 25
DeviceModel / ReferenceRegistriesClassStatus
NRG RF Transseptal Kit NTK-P710-8545
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-711-8545
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-710-8555N
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-710-8590S
FDA UDI
Class IIUnknown
SureFlex Steerable Guiding Sheath TSK85-32-BD-71M
FDA UDI
Class IIUnknown
VersaCross Steerable Access Solution VSTK-35P-180-85-BD-71M-D0
FDA UDI
Class IIUnknown
VersaCross Steerable Access Solution VSTK-35P-230-85-BD-71L-D1
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-P710-8555S
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-P710-8590
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-710-8555
FDA UDI
Class IIUnknown
VersaCross Access Solution VXSK-35J-180-81-55-D0
FDA UDI
Class IIUnknown
VersaCross Access Solution VXSK0021
FDA UDI
Class IIUnknown
VersaCross Steerable Access Solution VSTK0041
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-711-8555N
FDA UDI
Class IIUnknown
AnchorEntry Retractor, 60 mm PSZ-200-201
FDA UDI
Class IIUnknown
VersaCross Transseptal Sheath VXS8-35-63-37-D1
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-P710-8590N
FDA UDI
Class IIUnknown
VersaCross Large Access Solution VLAK0004
FDA UDI
Class IIUnknown
VersaCross Access Solution VXSK-35P-180-81-45-D1
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-P710-8555N
FDA UDI
Class IIUnknown
TorFlex Transseptal Guiding Sheath TF8-32-81-37
FDA UDI
Class IIUnknown
VersaCross Transseptal Sheath VXS85-35-63-90-D0
FDA UDI
Class IIActive
TorFlex Transseptal Guiding Sheath TF8-32-63-55
FDA UDI
Class IIUnknown
RFP-100A Connector Cable RFX-BAY-TS
FDA UDI
Class IIUnknown
AnchorEntry Retractor, Double Flange, 70 mm PSZ-200-206
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-710-8555S
FDA UDI
Class IIUnknown
VersaCross Steerable Access Solution VSTK0012
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-710-8590S
FDA UDI
Class IIUnknown
SupraCross Steerable Sheath SSS0006
FDA UDI
Class IIUnknown
VersaCross™ Steerable Access Solution VSTK0114
FDA UDI
Class IIActive
VersaCross Steerable Sheath VST85-35-BD-71S-D1
FDA UDI
Class IIUnknown
VersaCross Access Solution VXSK0004
FDA UDI
Class IIUnknown
VersaCross Transseptal Sheath VXS8-35-81-55-D1
FDA UDI
Class IIUnknown
VersaCross Steerable Sheath VST85-35-BD-71L-D1
FDA UDI
Class IIUnknown
TorFlex Transseptal Guiding Sheath TF85-32-81-45
FDA UDI
Class IIUnknown
TorFlex Transseptal Guiding Sheath TF85-32-63-45
FDA UDI
Class IIUnknown
VersaCross Steerable Access Solution VSTK0037
FDA UDI
Class IIUnknown
SureFlex Steerable Guiding Sheath TSK0006
FDA UDI
Class IIUnknown
RFP-100A Connector Cable RFX-BAY-TS
FDA UDI
Class IIActive
VersaCross Access Solution VXSK0005
FDA UDI
Class IIUnknown
VersaCross Steerable Access Solution VSTK0049
FDA UDI
Class IIUnknown
TorFlex Transseptal Guiding Sheath TF8-32-81-55
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-711-8590
FDA UDI
Class IIUnknown
VersaCross™ Large Access Solution VLAK0102
FDA UDI
Class IIActive
VersaCross Access Solution VXSK-35J-180-81-45-D0
FDA UDI
Class IIUnknown
Anchor Curved Tip Kerrison Rongeur PSZ-400-201
FDA UDI
Class IIUnknown
NRG Transseptal Needle NRG-89-C1
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-710-8555N
FDA UDI
Class IIUnknown
ExpanSure Large Access Transseptal Dilator ESD125-35-67-70-N
FDA UDI
Class IIUnknown
NRG RF Transseptal Kit NTK-P710-8590S
FDA UDI
Class IIUnknown

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