The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Glidesheath Slender Model Rm* Es6j10hqs, Glidesheath Slender Model Rm* Es6f16hq, Glidesheath Slender Model Rm * Rs6j10pq.
| Device ID | K122980 |
| 510k Number | K122980 |
| Device Name: | GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ |
| Classification | Introducer, Catheter |
| Applicant | Terumo Medical Corporation 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Daniel R Plonski |
| Correspondent | Daniel R Plonski 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 | 2012-09-26 |
| Decision Date | 2012-12-11 |
| Summary: | summary |