Impress Angiographic Catheter
FDA 510(k) K233268 · Merit Medical Systems, Inc.
510(k) numberK233268
Submission
- Device name
- Impress Angiographic Catheter
- Applicant
- Merit Medical Systems, Inc.
South Jordan, UT, US - Received
- September 29, 2023
- Decision date
- May 22, 2024
- 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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| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 08/08/2023SE |
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Questions and answers
When was Impress Angiographic Catheter cleared by the FDA?
Impress Angiographic Catheter (K233268) received a 510(k) decision of Substantially Equivalent on May 22, 2024, 236 days after the submission was received.
What is the product code of K233268?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.