The following data is part of a premarket notification filed by Millar Instruments, Inc. with the FDA for Mikro-cath, Model 825-0101.
| Device ID | K093111 |
| 510k Number | K093111 |
| Device Name: | MIKRO-CATH, MODEL 825-0101 |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Contact | Fatma Ali |
| Correspondent | Fatma Ali MILLAR INSTRUMENTS, INC. 6001-A GULF FREEWAY Houston, TX 77023 -5417 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868924000205 | K093111 | 000 |