The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Super Sheath Introducer Sheath.
| Device ID | K052557 |
| 510k Number | K052557 |
| Device Name: | SUPER SHEATH INTRODUCER SHEATH |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-16 |
| Decision Date | 2006-01-17 |
| Summary: | summary |