The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Millar Mikro-tip Catheter Pressure Transducer.
| Device ID | K883651 |
| 510k Number | K883651 |
| Device Name: | MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-26 |
| Decision Date | 1988-11-18 |