The following data is part of a premarket notification filed by Ashitaka Factory Of Terumo Corporation with the FDA for R2p Slenguide.
| Device ID | K161546 |
| 510k Number | K161546 |
| Device Name: | R2P SlenGuide |
| Classification | Catheter, Percutaneous |
| Applicant | ASHITAKA FACTORY OF TERUMO CORPORATION 150 MAIMAIGI-CHO Fujinomiya Shizuoka, JP 418-0015 |
| Contact | Phebe Varghese |
| Correspondent | Phebe Varghese TERUMO MEDICAL CORPORATION 265 DAVIDSON AVENUE, SUITE 320 Somerset, NJ 08873 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-03 |
| Decision Date | 2016-10-14 |
| Summary: | summary |