The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Mikro-tip Catheter Phonotrans.
| Device ID | K802830 |
| 510k Number | K802830 |
| Device Name: | MILLAR MIKRO-TIP CATHETER PHONOTRANS |
| Classification | System, Phonocatheter, Intracavitary |
| Applicant | MILLAR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXW |
| CFR Regulation Number | 870.1270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-10 |
| Decision Date | 1980-12-10 |