Advanced Cardiovascular-Coronary Guid
FDA 510(k) K842195 · Advanced Cardiovascular Systems, Inc.
510(k) numberK842195
Submission
- Device name
- Advanced Cardiovascular-Coronary Guid
- Applicant
- Advanced Cardiovascular Systems, Inc.
Santa Clara, CA, US - Received
- June 4, 1984
- Decision date
- July 13, 1984
- 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
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 |
|---|---|---|
| K012534 | Hi-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic CoatingDQX · Traditional | 01/24/2002SE |
| K000550 | Otw Megalink SDS Biliary Stent SystemFGE · Special | 03/17/2000SESU |
| K994229 | Veripath Peripheral Guiding CatheterDQY · Special | 02/25/2000SE |
| K992169 | Acs Hi-Torque Cross-It 400XT Guide WireDQX · Traditional | 10/28/1999SE |
| K990867 | RX Herculink 14 Biliary Stent System, Model 1005126-18,1005128-18,1005130-18,1005132-18,1…FGE · Traditional | 09/02/1999SESU |
| K963702 | Acs Hi-Torque Iron Man Guide WireDQX · Traditional | 01/22/1997SE |
| K962495 | Indeflator Plus 30/PLUS 30 Priority PACK9WITH THE.096 OR.115 Rotating Hemostatic Valve)MAV · Traditional | 09/12/1996SE |
| K961471 | Indeflator 20/30 Inflation Device and 20/30 Priority Pack (with the .096 or .115…MAV · Traditional | 05/08/1996SESK |
| K955175 | Acs Anchor Exchange DeviceDQX · Traditional | 04/05/1996SE |
| K953987 | Acs Tourgide Guiding CatheterDQY · Traditional | 12/07/1995SE |
Questions and answers
When was Advanced Cardiovascular-Coronary Guid cleared by the FDA?
Advanced Cardiovascular-Coronary Guid (K842195) received a 510(k) decision of Substantially Equivalent on July 13, 1984, 39 days after the submission was received.
What is the product code of K842195?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.