The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for R2p Destination Slender Guiding Sheath.
| Device ID | K171491 |
| 510k Number | K171491 |
| Device Name: | R2P Destination Slender Guiding Sheath |
| Classification | Introducer, Catheter |
| Applicant | Terumo Medical Corporation 950 Elkton Blvd Elkton, MD 21921 |
| Contact | Liang Lu |
| Correspondent | Liang Lu 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 | 2017-05-22 |
| Decision Date | 2017-10-05 |
| Summary: | summary |