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SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200483
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/21/2020
Days to Decision
84 days
Submission Type
Summary

SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200483
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/21/2020
Days to Decision
84 days
Submission Type
Summary