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SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183636
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/22/2019
Days to Decision
27 days
Submission Type
Summary

SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183636
510(k) Type
Special
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/22/2019
Days to Decision
27 days
Submission Type
Summary