The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Van-tec Ureteral Anesthe. Stone Displacement Cath..
| Device ID | K860337 |
| 510k Number | K860337 |
| Device Name: | VAN-TEC URETERAL ANESTHE. STONE DISPLACEMENT CATH. |
| Classification | Catheter, Urological |
| 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 | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-29 |
| Decision Date | 1986-03-25 |