Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
FDA 510(k) K221528 · Edwards Lifesciences, LLC
510(k) numberK221528
Submission
- Device name
- Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- May 26, 2022
- Decision date
- August 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXF – Catheter, Septostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5175
- Specialty
- Cardiovascular
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Questions and answers
When was Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter cleared by the FDA?
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter (K221528) received a 510(k) decision of Substantially Equivalent on August 22, 2022, 88 days after the submission was received.
What is the product code of K221528?
The FDA product code is DXF – Catheter, Septostomy, a Class II (moderate risk) device regulated under 21 CFR 870.5175.