The following data is part of a premarket notification filed by Autovage with the FDA for Minivage(r).
| Device ID | K911919 |
| 510k Number | K911919 |
| Device Name: | MINIVAGE(R) |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | AUTOVAGE 1631 CITATION DR. South Park, PA 15129 |
| Contact | Joseph P Rudolph |
| Correspondent | Joseph P Rudolph AUTOVAGE 1631 CITATION DR. South Park, PA 15129 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-30 |
| Decision Date | 1991-07-26 |