Opti-Flow Digital Subtraction Angiography Cat-Kit
FDA 510(k) K844854 · Vas-Cath of Canada , Ltd.
510(k) numberK844854
Submission
- Device name
- Opti-Flow Digital Subtraction Angiography Cat-Kit
- Applicant
- Vas-Cath of Canada , Ltd.
Ontario, L5a 3v3, CA - Received
- December 13, 1984
- Decision date
- May 21, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
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| 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 |
|---|---|---|
| K875188 | Luer Lock Connectors / Ridig P.V.C.LFJ · Traditional | 03/02/1988SE |
| K871817 | Vas-Cath Peritoneal Dialysis CatheterFJS · Traditional | 07/16/1987SE |
| K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K871487 | Vas-Cath Permanent Single Lumen Hemodialysis CathLFJ · Traditional | 06/12/1987SE |
| K863982 | Vas-Cath Pericardiocentesis Catheter, Set & TrayJCY · Traditional | 10/24/1986SE |
| K853283 | Vaccess TM 4006LFJ · Traditional | 08/22/1985SE |
| K844800 | Opti-Flow & Opti-Torque Angiographic CathetersDQO · Traditional | 05/16/1985SE |
| K850009 | Evans, Vas-Cath Epidural Needle & CatheterBSO · Traditional | 05/13/1985SE |
| K844434 | Vaccess 3000 Single Lumen Jugular Cannula-CathLFJ · Traditional | 03/13/1985SE |
| K844433 | Vaccess 2000 Single Lumen Subclavian CannulaLFJ · Traditional | 03/13/1985SE |
Questions and answers
When was Opti-Flow Digital Subtraction Angiography Cat-Kit cleared by the FDA?
Opti-Flow Digital Subtraction Angiography Cat-Kit (K844854) received a 510(k) decision of Substantially Equivalent on May 21, 1985, 159 days after the submission was received.
What is the product code of K844854?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.