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subpart-f—cardiovascular-therapeutic-devices/

FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K111284
510(k) Type: Traditional
Applicant: OSTIAL CORPORATION
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 8/17/2011
Days to Decision: 103 days
Submission Type: Summary

FDA Browser

subpart-f—cardiovascular-therapeutic-devices/

FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM

Page Type: Cleared 510(K)
PDF: FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number: K111284
510(k) Type: Traditional
Applicant: OSTIAL CORPORATION
Country: United States
FDA Decision: Substantially Equivalent
Decision Date: 8/17/2011
Days to Decision: 103 days
Submission Type: Summary