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FDA 510(k)

SUPER SHEATH INTRODUCER SHEATH

K-Number: K052557 · 2006-01-17

ApplicantTogo Medikit Co., Ltd.
Decision Date2006-01-17
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUPER SHEATH INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Togo Medikit Co., Ltd.. It received FDA 510(k) clearance on 2006-01-17 under 510(k) number K052557. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER SHEATH INTRODUCER SHEATH?

SUPER SHEATH INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 2006-01-17. The listed applicant is Togo Medikit Co., Ltd.. The 510(k) number is K052557.

When did SUPER SHEATH INTRODUCER SHEATH receive FDA 510(k) clearance?

SUPER SHEATH INTRODUCER SHEATH received FDA 510(k) clearance on 2006-01-17, under 510(k) number K052557.

Who is the listed applicant for SUPER SHEATH INTRODUCER SHEATH?

The FDA 510(k) record lists Togo Medikit Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER SHEATH INTRODUCER SHEATH?

The FDA product code for SUPER SHEATH INTRODUCER SHEATH is DRE.

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Other records listing Togo Medikit Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241230Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008K200379Super SheathK190001Supercath 5K172496SUPERCATH 5 (26G)K160592SUPERCATH 6K121504SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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