Viewflex Plus Ice Catheter
FDA 510(k) K101239 · St Jude Medical
510(k) numberK101239
Submission
- Device name
- Viewflex Plus Ice Catheter
- Applicant
- St Jude Medical
St. Paul, MN, US - Received
- May 3, 2010
- Decision date
- June 2, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Viewflex Plus Ice Catheter cleared by the FDA?
Viewflex Plus Ice Catheter (K101239) received a 510(k) decision of Substantially Equivalent on June 2, 2010, 30 days after the submission was received.
What is the product code of K101239?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.