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Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192164
510(k) Type
Traditional
Applicant
Olympus Medical Systems Corp.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
3/6/2020
Days to Decision
210 days
Submission Type
Summary

Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192164
510(k) Type
Traditional
Applicant
Olympus Medical Systems Corp.
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
3/6/2020
Days to Decision
210 days
Submission Type
Summary