pNOVUS 21 Microcatheter
FDA 510(k) K242420 · Phenox, Ltd.
510(k) numberK242420
Submission
- Device name
- pNOVUS 21 Microcatheter
- Applicant
- Phenox, Ltd.
Galway, IE - Received
- August 15, 2024
- Decision date
- November 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
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| 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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| K221279 | pNOVUS 21 MicrocatheterDQO · Traditional | 11/28/2022SE |
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Questions and answers
When was pNOVUS 21 Microcatheter cleared by the FDA?
pNOVUS 21 Microcatheter (K242420) received a 510(k) decision of Substantially Equivalent on November 12, 2024, 89 days after the submission was received.
What is the product code of K242420?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.