The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Glidesheath.
| Device ID | K152173 |
| 510k Number | K152173 |
| Device Name: | Glidesheath |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-04 |
| Decision Date | 2015-12-01 |
| Summary: | summary |