Last synced on 10 January 2025 at 11:05 pm

HALO 360 & SIZING BALLOON, MODEL 3441C

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093855
510(k) Type
Special
Applicant
BARRX MEDICAL, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2010
Days to Decision
30 days
Submission Type
Summary

HALO 360 & SIZING BALLOON, MODEL 3441C

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K093855
510(k) Type
Special
Applicant
BARRX MEDICAL, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/2010
Days to Decision
30 days
Submission Type
Summary