510(k) K914555

WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) by Med Institute, Inc. — Product Code DRE

K914555 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)". The FDA issued a decision of Substantially Equivalent on January 3, 1992. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Med Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1992
Date Received
October 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type