Nmi Microcatheter
FDA 510(k) K121954 · Navilyst Medical, Inc.
510(k) numberK121954
Submission
- Device name
- Nmi Microcatheter
- Applicant
- Navilyst Medical, Inc.
Marlborough, MA, US - Received
- July 3, 2012
- Decision date
- July 17, 2012
- 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
Other 510(k)s with product code DQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K163452 | PICC Maximal Barrier Nursing KitLJS · Special | 02/03/2017SESK |
| K161866 | BioFlo Midline CatheterFOZ · Traditional | 09/08/2016SE |
| K151239 | Nmi Dual Port IILJT · Traditional | 06/06/2016SE |
| K153228 | NMI Port, NMI Port IILJT · Special | 12/04/2015SE |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCLJS · Special | 09/24/2015SE |
| K152069 | Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage…FGE · Traditional | 09/24/2015SE |
| K150407 | BioFlo Midline CatheterFOZ · Abbreviated | 05/15/2015SE |
| K150527 | Xcela Power Injectable PICCLJS · Special | 03/31/2015SE |
| K150448 | NMI PICC III and NMI PICC IVLJS · Special | 03/19/2015SE |
| K142616 | PICC Maximal Barrier Nursing KitLJS · Special | 10/14/2014SE |
Questions and answers
When was Nmi Microcatheter cleared by the FDA?
Nmi Microcatheter (K121954) received a 510(k) decision of Substantially Equivalent on July 17, 2012, 14 days after the submission was received.
What is the product code of K121954?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.