The following data is part of a premarket notification filed by Microvasive with the FDA for Aspiration & Irrigation Catheter.
| Device ID | K833331 |
| 510k Number | K833331 |
| Device Name: | ASPIRATION & IRRIGATION CATHETER |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | MICROVASIVE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-27 |
| Decision Date | 1983-11-14 |