The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acunav Diagnostic Ultrasound Catheter.
| Device ID | K992631 |
| 510k Number | K992631 |
| Device Name: | ACUNAV DIAGNOSTIC ULTRASOUND CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ACUSON CORP. 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein ACUSON CORP. 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 1999-12-15 |
| Summary: | summary |