510(k) K812944

MILLAR MIKRO-TIP CATHETER PRESSURE TRAN. by Millar Instruments, Inc. — Product Code DRF

K812944 is an FDA 510(k) premarket notification submitted by Millar Instruments, Inc. for the device "MILLAR MIKRO-TIP CATHETER PRESSURE TRAN.". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. Millar Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
October 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type