The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Mikro-tip Doppler Catheter.
Device ID | K896264 |
510k Number | K896264 |
Device Name: | MILLAR MIKRO-TIP DOPPLER CATHETER |
Classification | Transducer, Ultrasonic |
Applicant | MILLAR INSTRUMENTS, INC. P.O. BOX 18227 Houston, TX 77223 |
Contact | Robert Mcnamer |
Correspondent | Robert Mcnamer MILLAR INSTRUMENTS, INC. P.O. BOX 18227 Houston, TX 77223 |
Product Code | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-31 |
Decision Date | 1990-01-24 |