The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Super Sheath Xl Introducer Sheath.
| Device ID | K060190 |
| 510k Number | K060190 |
| Device Name: | SUPER SHEATH XL INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| Applicant | TOGO MEDIKIT CO., LTD. 5905 NATHAN LANE MAIL STOP P-25 Plymouth, MN 55442 |
| Contact | Heidi M Erickson |
| Correspondent | Heidi M Erickson TOGO MEDIKIT CO., LTD. 5905 NATHAN LANE MAIL STOP P-25 Plymouth, MN 55442 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-24 |
| Decision Date | 2006-04-04 |
| Summary: | summary |