Microcatheter
FDA 510(k) K173560 · Surmodics,Inc.
510(k) numberK173560
Submission
- Device name
- Microcatheter
- Applicant
- Surmodics,Inc.
Eden Prairie, MN, US - Received
- November 17, 2017
- Decision date
- January 12, 2018
- 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 Microcatheter cleared by the FDA?
Microcatheter (K173560) received a 510(k) decision of Substantially Equivalent on January 12, 2018, 56 days after the submission was received.
What is the product code of K173560?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.