Microcatheter
FDA 510(k) K232647 · Surmodics,Inc.
510(k) numberK232647
Submission
- Device name
- Microcatheter
- Applicant
- Surmodics,Inc.
Eden Prairie, MN, US - Received
- August 31, 2023
- Decision date
- September 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Microcatheter cleared by the FDA?
Microcatheter (K232647) received a 510(k) decision of Substantially Equivalent on September 29, 2023, 29 days after the submission was received.
What is the product code of K232647?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.