The following data is part of a premarket notification filed by Scion Cardiovascular, Inc. with the FDA for Scipro(tm) Flexible Stone Dislodger And Retrieval Set.
| Device ID | K001563 |
| 510k Number | K001563 |
| Device Name: | SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET |
| Classification | Dislodger, Stone, Flexible |
| Applicant | SCION CARDIOVASCULAR, INC. 14256 SW 119 AVE. Miami, FL 33186 |
| Contact | David B Jones |
| Correspondent | David B Jones SCION CARDIOVASCULAR, INC. 14256 SW 119 AVE. Miami, FL 33186 |
| Product Code | FGO |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-11-22 |