The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Nonmagnectic Mikro-tip Catheter Press. Tran.
| Device ID | K915775 |
| 510k Number | K915775 |
| Device Name: | MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN |
| Classification | Transducer, Pressure, Catheter Tip |
| 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 | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-04-20 |