The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Helical Stone Basket (disposable).
| Device ID | K871779 |
| 510k Number | K871779 |
| Device Name: | HELICAL STONE BASKET (DISPOSABLE) |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
| Contact | James F Vance |
| Correspondent | James F Vance VAN-TEC, INC. P.O. BOX 26 Spencer, IN 47460 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-06 |
| Decision Date | 1987-06-17 |