KDL MEDICAL, INC.

Address:885 E Collins Blvd Ste 110,RICHARDSON,TX,75081,US

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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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (8) Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (DXZ) (2)

Premarket Exempt

No Yes

Clear

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002005 Catalog Number :

Device Description : Vessel Shunt 1.00mm Tapered Tip, 12mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002012 Catalog Number :

Device Description : Vessel Shunt 1.50mm Tapered Tip, 12mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Bulb Tip Coronary Artery Shunts - 00899054002029 Catalog Number :

Device Description : Vessel Shunt 1.50mm Bulb Tip, 12mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Bulb Tip Coronary Artery Shunts - 00899054002036 Catalog Number :

Device Description : Vessel Shunt 3.00mm Bulb Tip, 30mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Bulb Tip Coronary Artery Shunts - 00899054002043 Catalog Number :

Device Description : Vessel Shunt 2.50mm Bulb Tip, 30mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Bulb Tip Coronary Artery Shunts - 00899054002050 Catalog Number :

Device Description : Vessel Shunt 4.00mm Bulb Tip, 30mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Mannequin™ Endoventricular Shaper - 00899054002067 Catalog Number :

Device Description : Mannequin™ Endoventricular Shaper, 80cc

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002074 Catalog Number :

Device Description : Vessel Shunt 1.25mm Tapered Tip, 12mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002081 Catalog Number :

Device Description : Vessel Shunt 1.75mm Tapered Tip, 12mm Shaft

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Mannequin™ Endoventricular Shaper - 00899054002098 Catalog Number :

Device Description : Mannequin™ Endoventricular Shaper, 90cc

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

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