Micrus Microcatheter
FDA 510(k) K032624 · Micrus Corp.
510(k) numberK032624
Submission
- Device name
- Micrus Microcatheter
- Applicant
- Micrus Corp.
Sunnyvale, CA, US - Received
- August 26, 2003
- Decision date
- September 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| 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 |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| 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 |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K033813 | Micrus Modified Microcoil System, CerecyteHCG · Traditional | 02/04/2004SE |
| K032872 | Micrus Microcoil SystemHCG · Traditional | 11/28/2003SE |
| K031578 | Micrus Microcoil Systems, Models Hel, SPH, STR, FSR and HSRHCG · Traditional | 08/01/2003SE |
| K022420 | Micrus Stretch-Resistant Microcoil System, MSR01HCG · Traditional | 10/22/2002SE |
| K002056 | Micrus Microcoil Delivery System, MDS03HCG · Traditional | 01/11/2001SE |
Questions and answers
When was Micrus Microcatheter cleared by the FDA?
Micrus Microcatheter (K032624) received a 510(k) decision of Substantially Equivalent on September 10, 2003, 15 days after the submission was received.
What is the product code of K032624?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.