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 | K853138 |
| 510k Number | K853138 |
| Device Name: | MILLAR MIKRO-TIP DOPPLER CATHETER |
| Classification | Transducer, Ultrasonic |
| Applicant | MILLAR INSTRUMENTS, INC. P.O. BOX 18227 Houston, TX 77223 |
| Contact | Robert D Miers |
| Correspondent | Robert D Miers 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 | 1985-07-26 |
| Decision Date | 1985-10-29 |