510(k) K011790

MICROCRUISER PLUS INTRODUCER SET by Medical Device Technologies, Inc. — Product Code DYB

K011790 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "MICROCRUISER PLUS INTRODUCER SET". The FDA issued a decision of Substantially Equivalent on September 5, 2001. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2001
Date Received
June 8, 2001
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