Last synced on 25 April 2025 at 11:05 pm

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243938
510(k) Type
Special
Applicant
Scientia Vascular Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/2025
Days to Decision
102 days
Submission Type
Summary

Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K243938
510(k) Type
Special
Applicant
Scientia Vascular Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/1/2025
Days to Decision
102 days
Submission Type
Summary