ZIEN MEDICAL TECHNOLOGIES, INC.

Address:2490 South 300 West,Salt Lake City,UT,84115,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, Percutaneous (DQY) (10)

Premarket Exempt

No Yes

Clear

XableCath - 00853989006002 Catalog Number : XC-014-065A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006019 Catalog Number : XC-014-090A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006026 Catalog Number : XC-014-145A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006033 Catalog Number : XC-018-065A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006040 Catalog Number : XC-018-090A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006057 Catalog Number : XC-018-145A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006064 Catalog Number : XC-035-065A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006071 Catalog Number : XC-035-090A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006088 Catalog Number : XC-035-145A

Device Description : XableCath is an over-the-wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

XableCath - 00853989006095 Catalog Number : XC-014-065B

Device Description : XableCath is an over the wire catheter for facilitating guide wire and catheter

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

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