The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Glidesheath Slender.
| Device ID | K142183 |
| 510k Number | K142183 |
| Device Name: | GLIDESHEATH SLENDER |
| Classification | Introducer, Catheter |
| Applicant | Terumo Medical Corporation 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Erin Doyle |
| Correspondent | Erin Doyle Terumo Medical Corporation 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 | 2014-08-08 |
| Decision Date | 2014-11-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLIDESHEATH SLENDER 85625677 4597661 Live/Registered |
Terumo Kabushiki Kaisha 2012-05-15 |