The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Avanar F/x 2.9f Intravascular Ultrasound Imaging Catheter, Model 85700.
| Device ID | K000820 |
| 510k Number | K000820 |
| Device Name: | AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700 |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | ENDOSONICS CORP. 1401 ROCKVILLE PIKE SUITE 300 Rockville, MD 20850 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula ENDOSONICS CORP. 1401 ROCKVILLE PIKE SUITE 300 Rockville, MD 20850 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-06-05 |