The following data is part of a premarket notification filed by Terumo Medical Coporation with the FDA for Glidesheath Slender Tibial Pedal Kit.
| Device ID | K193160 |
| 510k Number | K193160 |
| Device Name: | Glidesheath Slender Tibial Pedal Kit |
| Classification | Introducer, Catheter |
| Applicant | Terumo Medical Coporation 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Liang Lu |
| Correspondent | Liang Lu Terumo Medical Coporation 950 Elkton Blvd. Elkton, MD 21921 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2019-12-03 |