Last synced on 10 January 2025 at 11:05 pm

MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083711
510(k) Type
Special
Applicant
BARRX MEDICAL, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/2/2009
Days to Decision
49 days
Submission Type
Summary

MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083711
510(k) Type
Special
Applicant
BARRX MEDICAL, INCORPORATED
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/2/2009
Days to Decision
49 days
Submission Type
Summary