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) (5) Stabilizer,Heart (MWS) (5)

Premarket Exempt

No Yes

Clear

Viper II Heart Stabilizer - 00899054002500 Catalog Number :

Device Description : Heart Stabilizer, Vacuum, Q Base

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Heart Stabilizer Nylon Occ FsTrac - 00899054002517 Catalog Number :

Device Description : Heart Stabilizer, Nylon Textured Feet w/ Occluders

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Heart Stabilizer Lt Metal w/Occ - 00899054002524 Catalog Number :

Device Description : Heart Stabilizer, Light Metal Textured Feet w/ Occluders

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

TRIPOD Heart Stabilizer Nylon Blwr/Occ - 00899054002531 Catalog Number :

Device Description : Heart Stabilizer, Nylon Textured Feet w/ Blower, Occluders

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : Yes

Device Count : 1

Viper II Apical Lift - 00899054002548 Catalog Number :

Device Description : Apical Lift Positioner, Q Base

Device Class : 1

Duns Number: 791048924

Premarket Exempt : Yes

Product Code : MWS

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002555 Catalog Number :

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

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002562 Catalog Number :

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

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002579 Catalog Number :

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

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002586 Catalog Number :

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

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

Sof-Flo Atraumatic Coronary Artery Shunt - 00899054002593 Catalog Number :

Device Description : Vessel Shunt 2.00mm Tapered Tip, 12mm Shaft, ST

Device Class : 2

Duns Number: 791048924

Premarket Exempt : No

Product Code : DWF

Prescription Use : No

Device Count : 1

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