SUMMIT ACCESS LLC

Address:14 Inverness Dr E Ste H136,Englewood,CO,80112,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

Dilator, Vessel, For Percutaneous Catheterization (DRE) (5) Accessories, Catheter (KGZ) (3)

Premarket Exempt

No Yes

Clear

MicroTaper™ Safety Introducer Set - 10860327000216 Catalog Number :

Device Class : 2

Duns Number: 021348782

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

MicroTaper™ Safety Introducer Set - 10860327000223 Catalog Number :

Device Class : 2

Duns Number: 021348782

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

MicroTaper™ Safety Introducer Set - 10860327000230 Catalog Number :

Device Class : 2

Duns Number: 021348782

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

MicroTaper™ Safety Introducer Set - 10860327000247 Catalog Number :

Device Class : 2

Duns Number: 021348782

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

MicroTaper™ Safety Introducer Set - 10860327000254 Catalog Number :

Device Class : 2

Duns Number: 021348782

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

MicroTaper™ NV Non-Vascular Safety Introducer Set - 10860327000278 Catalog Number :

Device Class : 1

Duns Number: 021348782

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

MicroTaper™ NV Non-Vascular Safety Introducer Set - 10860327000285 Catalog Number :

Device Class : 1

Duns Number: 021348782

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

MicroTaper™ NV Non-Vascular Safety Introducer Set - 10860327000292 Catalog Number :

Device Class : 1

Duns Number: 021348782

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

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