Baylis Médicale Cie Inc

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Catheter, Septostomy (DXF) (7) Catheter, Percutaneous (DQY) (6) Dilator, Vessel, For Percutaneous Catheterization (DRE) (6) Introducer, Catheter (DYB) (6) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2) Wire, Guide, Catheter (DQX) (2)

Premarket Exempt

No Yes

Clear

NRG RF Transseptal Kit - 00685447000532 Catalog Number :

Device Description : 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack 1 x NRG Transseptal Needle; 1 x TorFlex Transseptal Guiding Sheath; 1 x ProTrack Pigtail Wire; 1 x Adult Dispersive Electrode

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DYB, DRE, DQY, DXF

Prescription Use : Yes

Device Count : 1

NRG RF Transseptal Kit - 00685447000549 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DYB, DRE, DQY, DXF

Prescription Use : Yes

Device Count : 1

NRG RF Transseptal Kit - 00685447000556 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DYB, DRE, DQY, DXF

Prescription Use : Yes

Device Count : 1

NRG RF Transseptal Kit - 00685447000563 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DYB, DRE, DQY, DXF

Prescription Use : Yes

Device Count : 1

NRG RF Transseptal Kit - 00685447000570 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DYB, DRE, DQY, DXF

Prescription Use : Yes

Device Count : 1

NRG RF Transseptal Kit - 00685447000587 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DYB, DRE, DQY, DXF

Prescription Use : Yes

Device Count : 1

RFP-100A Footswitch - 00685447000594 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Nykanen Radiofrequency Wire - 00685447000600 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : GEI, DXF

Prescription Use : Yes

Device Count : 1

ProTrack Microcatheter - 00685447000617 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

ProTrack Microcatheter - 00685447000624 Catalog Number :

Device Class : 2

Duns Number: 249225954

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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