Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
FDA 510(k) K241230 · Togo Medikit Co., Ltd.
510(k) numberK241230
Submission
- Device name
- Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008
- Applicant
- Togo Medikit Co., Ltd.
Miyazaki, JP - Received
- May 2, 2024
- Decision date
- September 17, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K160592 | Supercath 6FOZ · Traditional | 08/12/2016SE |
| K141070 | Super SheathDRE · Traditional | 01/15/2015SE |
| K140419 | SUPERCATH5FOZ · Traditional | 05/12/2014SE |
| K121504 | Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsDYB · Traditional | 09/27/2012SE |
| K112290 | Supercath Z3VFOZ · Traditional | 04/16/2012SE |
| K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XXFOZ · Special | 12/17/2009SE |
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Questions and answers
When was Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 cleared by the FDA?
Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 (K241230) received a 510(k) decision of Substantially Equivalent on September 17, 2024, 138 days after the submission was received.
What is the product code of K241230?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.