Disposable High Pressure Injection Lines with and Without Rotating Adapters
FDA 510(k) K071196 · Coeur, Inc.
510(k) numberK071196
Submission
- Device name
- Disposable High Pressure Injection Lines with and Without Rotating Adapters
- Applicant
- Coeur, Inc.
Lebanon, TN, US - Received
- April 30, 2007
- Decision date
- September 6, 2007
- 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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|---|---|---|---|
| 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 |
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|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…DXT · Traditional | 08/18/2017SE |
| K161471 | MR Syringe Dual Pack for Solaris InjectorsDXT · Traditional | 10/06/2016SE |
| K150902 | 330psi Extension Y-Line with Dual Check ValveDXT · Traditional | 10/22/2015SE |
| K142745 | 125mL CT SyringeDXT · Traditional | 04/01/2015SE |
| K140469 | MR Syringe Dual PackDXT · Traditional | 07/28/2014SE |
| K133600 | Coeur, Inc. Frontload for Optivantage Power InjectorDXT · Traditional | 04/30/2014SE |
| K120892 | Disposable 330PSI Extension LinesDXT · Traditional | 06/10/2013SE |
| K113498 | Disposable Torque DeviceDQX · Traditional | 07/20/2012SE |
| K113132 | Disposable Hemostatic Y-ConnectorsDTL · Traditional | 01/20/2012SE |
| K090487 | Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model SY-125…DXT · Traditional | 10/19/2009SE |
Questions and answers
When was Disposable High Pressure Injection Lines with and Without Rotating Adapters cleared by the FDA?
Disposable High Pressure Injection Lines with and Without Rotating Adapters (K071196) received a 510(k) decision of Substantially Equivalent on September 6, 2007, 129 days after the submission was received.
What is the product code of K071196?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.