Impress Angiographic Catheter
FDA 510(k) K191608 · Merit Medical Systems, Inc.
510(k) numberK191608
Submission
- Device name
- Impress Angiographic Catheter
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- June 17, 2019
- Decision date
- July 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was Impress Angiographic Catheter cleared by the FDA?
Impress Angiographic Catheter (K191608) received a 510(k) decision of Substantially Equivalent on July 16, 2019, 29 days after the submission was received.
What is the product code of K191608?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.