ACCESS SCIENTIFIC, LLC

Address:3910 Sorrento Valley Blvd Ste 200,San Diego,CA,92121,US

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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

Introducer, Catheter (DYB) (3) Peripheral Catheter Insertion Kit (OWL) (2) Catheter Introducer Kit (OFD) (1)

Premarket Exempt

No Yes

Clear

POWERWAND - 10859821006497 Catalog Number : 76416

Device Description : POWERWAND Quick Kit 3Fr X 6cm

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

CVC WAND XL - 10859821006503 Catalog Number : 93103

Device Description : The CVC WAND XL Max Barrier Kit

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : OFD

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL-REC - 10859821006510 Catalog Number : 95001

Device Description : The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. The POWERWAND XL-REC Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND - 10859821006527 Catalog Number : 92019

Device Description : The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Ne The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL - 10859821006534 Catalog Number : 94119

Device Description : The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZE The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

POWERWAND™ XL - 10859821006541 Catalog Number : 94131

Device Description : POWERWAND™ XL Quick Kit 5Fr X 10cm Bifurcated

Device Class : 2

Duns Number: 079290879

Premarket Exempt : No

Product Code : OWL

Prescription Use : Yes

Device Count : 1

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