The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Pinnacle R/o Or Redifocus Introducer R/o (comprised Of A Sheath & Dilator).
| Device ID | K984260 |
| 510k Number | K984260 |
| Device Name: | PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) |
| 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 | 1998-11-25 |
| Decision Date | 1999-01-26 |
| Summary: | summary |