510(k) K090372

THE WAND MICROACCESS SAFETY INTRODUCER by Access Scientific, Inc. — Product Code DYB

K090372 is an FDA 510(k) premarket notification submitted by Access Scientific, Inc. for the device "THE WAND MICROACCESS SAFETY INTRODUCER". The FDA issued a decision of Substantially Equivalent on March 30, 2009. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Access Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2009
Date Received
February 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type