510(k) K915775

MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN by Millar Instruments, Inc. — Product Code DXO

K915775 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN". The FDA issued a decision of Substantially Equivalent on April 20, 1992. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1992
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type