The following data is part of a premarket notification filed by Omni-tract Surgical, Div. Minn. Scientific, Inc. with the FDA for Intraluminal Artery Stripper.
| Device ID | K913803 |
| 510k Number | K913803 |
| Device Name: | INTRALUMINAL ARTERY STRIPPER |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 403 COUNTY ROAD, E2 WEST St. Paul, MN 55112 |
| Contact | Dale Stull |
| Correspondent | Dale Stull OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 403 COUNTY ROAD, E2 WEST St. Paul, MN 55112 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1992-04-24 |