Last synced on 12 October 2025 at 8:21 pm

ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100303
510(k) Type
Traditional
Applicant
ANGIOSCORE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/22/2010
Days to Decision
47 days
Submission Type
Summary

ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100303
510(k) Type
Traditional
Applicant
ANGIOSCORE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/22/2010
Days to Decision
47 days
Submission Type
Summary