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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 74543527202021 | K060190 | 000 |
| 14543527185247 | K060190 | 000 |
| 14543527185230 | K060190 | 000 |
| 14543527185223 | K060190 | 000 |
| 74543527185218 | K060190 | 000 |
| 14543527185209 | K060190 | 000 |
| 74543527185195 | K060190 | 000 |
| 14543527202029 | K060190 | 000 |
| 14543527201947 | K060190 | 000 |
| 14543527201930 | K060190 | 000 |
| 14543527202005 | K060190 | 000 |
| 14543527201985 | K060190 | 000 |
| 14543527201954 | K060190 | 000 |
| 14543527185254 | K060190 | 000 |
| 14543527185216 | K060190 | 000 |
| 14543527185193 | K060190 | 000 |
| 74543527185256 | K060190 | 000 |
| 14543527185261 | K060190 | 000 |
| 14543527202012 | K060190 | 000 |
| 74543527202007 | K060190 | 000 |
| 14543527201992 | K060190 | 000 |
| 74543527201987 | K060190 | 000 |
| 14543527201978 | K060190 | 000 |
| 14543527201961 | K060190 | 000 |
| 74543527201956 | K060190 | 000 |
| 74543527201949 | K060190 | 000 |
| 74543527201932 | K060190 | 000 |
| 14543527201923 | K060190 | 000 |
| 14543527201916 | K060190 | 000 |
| 14543527185308 | K060190 | 000 |
| 14543527185292 | K060190 | 000 |
| 14543527185285 | K060190 | 000 |
| 14543527185278 | K060190 | 000 |
| 74543527202014 | K060190 | 000 |