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FDA 510(k)

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008

K-Number: K241230 · 2024-09-17

ApplicantTogo Medikit Co., Ltd.
Decision Date2024-09-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is a medical device manufactured by Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2024-09-17 under approval number K241230. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008?

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is a medical device that received FDA 510(k) clearance on 2024-09-17. It is manufactured by Togo Medikit Co., Ltd.. The 510(k) number is K241230.

When was Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 approved by the FDA?

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 received FDA 510(k) clearance on 2024-09-17, under approval number K241230.

What company makes Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008?

Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is manufactured by Togo Medikit Co., Ltd..

What is the FDA product code for Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008?

The FDA product code for Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 is DYB.

Other Devices by Togo Medikit Co., Ltd.

K160592SUPERCATH 6 K172496SUPERCATH 5 (26G) K190001Supercath 5 K200379Super Sheath

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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