The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Modification To Pinnacle Roii Hiflow Introducer Sheath.
| Device ID | K062446 |
| 510k Number | K062446 |
| Device Name: | MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Mark Unterreiner |
| Correspondent | Mark Unterreiner TERUMO MEDICAL CORP. 950 Elkton Blvd. 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 | 2006-08-22 |
| Decision Date | 2006-10-23 |
| Summary: | summary |