The following data is part of a premarket notification filed by Image-guided Neurologics, Inc. with the FDA for Aspiration/irrigation Catheter, Model Ac-1000.
| Device ID | K992796 |
| 510k Number | K992796 |
| Device Name: | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 |
| Classification | Catheter, Ventricular |
| Applicant | IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Contact | Michael Renner |
| Correspondent | Michael Renner IMAGE-GUIDED NEUROLOGICS, INC. 2290 EAU GALLIE BLVD. Melbourne, FL 32935 |
| Product Code | HCA |
| CFR Regulation Number | 882.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-19 |
| Decision Date | 1999-10-25 |