Basixtouch
FDA 510(k) K130566 · Merit Medical Systems, Inc.
510(k) numberK130566
Submission
- Device name
- Basixtouch
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- March 4, 2013
- Decision date
- June 19, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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Questions and answers
When was Basixtouch cleared by the FDA?
Basixtouch (K130566) received a 510(k) decision of Substantially Equivalent on June 19, 2013, 107 days after the submission was received.
What is the product code of K130566?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.