SOFIA 88 Catheter
FDA 510(k) K214024 · MicroVention, Inc.
510(k) numberK214024
Submission
- Device name
- SOFIA 88 Catheter
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- December 22, 2021
- Decision date
- September 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was SOFIA 88 Catheter cleared by the FDA?
SOFIA 88 Catheter (K214024) received a 510(k) decision of Substantially Equivalent on September 12, 2022, 264 days after the submission was received.
What is the product code of K214024?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.