The following data is part of a premarket notification filed by Togo Medikit Co., Ltd. with the FDA for Super Sheath Introducer Sheath And Super Sheath Introducer Sheath Sets.
| Device ID | K121504 |
| 510k Number | K121504 |
| Device Name: | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS |
| Classification | Introducer, Catheter |
| Applicant | TOGO MEDIKIT CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Contact | Heather Crawford |
| Correspondent | Heather Crawford TOGO MEDIKIT CO., LTD. 611 WEST 5TH STREET Austin, TX 78701 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14543527226919 | K121504 | 000 |
| 14543527226902 | K121504 | 000 |
| 74543527226898 | K121504 | 000 |
| 74543527226881 | K121504 | 000 |
| 14543527199763 | K121504 | 000 |
| 14543527199756 | K121504 | 000 |
| 74543527199741 | K121504 | 000 |
| 74543527199734 | K121504 | 000 |