Data / Medical devices / Japan / Togo Medikit Co., Ltd.
Togo Medikit Co., Ltd.: FDA-registered device maker in HYUGA CITY Miyazaki, Japan, 8 510(k) clearances
Togo Medikit Co., Ltd. is registered with the FDA (registration 9612126) in HYUGA CITY Miyazaki, Japan. It lists 5 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 19, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9612126
- FEI number
- 3002807548
- Address
- 17148-6 Aza Kamekawa Oaza Hichiya, HYUGA CITY Miyazaki, Japan, 883-0062
- Owner or operator
- TOGO MEDIKIT CO., LTD. (8030371)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- April 26, 2006
- Registered through
- 2026
- Brand names listed
- Mongoose Angiographic Catheter, SUPER SHEATH XL INTRODUCER SHEATH, Super Sheath, Super Sheath CBDE, Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Set, Super Sheath R/O, Super Sheath, Super Sheath R/O, Supercath 5 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Catheter, Peritoneal | GBW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2020 | K200379 | Super Sheath | DRE | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| September 20, 2019 | K190001 | Supercath 5 | FOZ | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| March 23, 2018 | K172496 | SUPERCATH 5 (26G) | FOZ | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| January 15, 2015 | K141070 | SUPER SHEATH | DRE | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| May 12, 2014 | K140419 | SUPERCATH5 | FOZ | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| September 27, 2012 | K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS | DYB | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
| July 11, 2012 | K113819 | MONGOOSE ANGIOGRAPHIC CATHETER | DQO | Substantially Equivalent | Pediacath, Inc. | accessdata.fda.gov |
| April 4, 2006 | K060190 | SUPER SHEATH XL INTRODUCER SHEATH | DYB | Substantially Equivalent | Togo Medikit Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Introducer, Catheter
- All makers of Catheter, Intravascular, Diagnostic
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Catheter, Peritoneal
Updated March 19, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.