The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Pinnacle R/o Ii Or Radifocus Introducer Ii.
| Device ID | K003424 |
| 510k Number | K003424 |
| Device Name: | PINNACLE R/O II OR RADIFOCUS INTRODUCER II |
| Classification | Introducer, Catheter |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis TERUMO MEDICAL CORP. 125 BLUE BALL RD. 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 | 2000-11-03 |
| Decision Date | 2000-11-21 |