Ventrax Delivery System
FDA 510(k) K242873 · Merit Medical Systems, Inc.
510(k) numberK242873
Submission
- Device name
- Ventrax Delivery System
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- September 23, 2024
- Decision date
- January 15, 2025
- 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 Ventrax Delivery System cleared by the FDA?
Ventrax Delivery System (K242873) received a 510(k) decision of Substantially Equivalent on January 15, 2025, 114 days after the submission was received.
What is the product code of K242873?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.