FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
K Number: K241230
·
Decision Sep 17, 2024
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
17
Review Days
138
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Basic Information
- Device Name
- Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
- K Number
- K241230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Togo Medikit Co., Ltd.
- Date Received
- May 2, 2024
- Decision Date
- September 17, 2024
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Togo Medikit Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K200379 | Super Sheath | Mar 19, 2020 | Substantially Equivalent |
| K190001 | Supercath 5 | Sep 20, 2019 | Substantially Equivalent |
| K172496 | SUPERCATH 5 (26G) | Mar 23, 2018 | Substantially Equivalent |
| K160592 | SUPERCATH 6 | Aug 12, 2016 | Substantially Equivalent |
| K141070 | SUPER SHEATH | Jan 15, 2015 | Substantially Equivalent |
| K140419 | SUPERCATH5 | May 12, 2014 | Substantially Equivalent |
| K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS | Sep 27, 2012 | Substantially Equivalent |
| K112290 | SUPERCATH Z3V | Apr 16, 2012 | Substantially Equivalent |
| K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX | Dec 17, 2009 | Substantially Equivalent |
| K081953 | SUPERCATH 5 | Mar 12, 2009 | Substantially Equivalent |