Last synced on 6 December 2024 at 11:05 pm

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213031
510(k) Type
Traditional
Applicant
Zoll Circulation, Inc.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/20/2021
Days to Decision
90 days
Submission Type
Summary

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213031
510(k) Type
Traditional
Applicant
Zoll Circulation, Inc.
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
12/20/2021
Days to Decision
90 days
Submission Type
Summary