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ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091310
510(k) Type
Traditional
Applicant
DFINE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/2010
Days to Decision
464 days
Submission Type
Summary

ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K091310
510(k) Type
Traditional
Applicant
DFINE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/11/2010
Days to Decision
464 days
Submission Type
Summary