Quinton Q-Cath, Model 000460
FDA 510(k) K021906 · Quinton, Inc.
510(k) numberK021906
Submission
- Device name
- Quinton Q-Cath, Model 000460
- Applicant
- Quinton, Inc.
Bothell, WA, US - Received
- June 10, 2002
- Decision date
- September 4, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
Other 510(k)s with product code DQK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
More from iRhythm Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032038 | Pyramis ECG Management System Model Numbers, 92600 and 92601DQK · Abbreviated | 09/05/2003SE |
| K003576 | Q-Tel RMS (Rehabilitation Management System), Model 000503DSI · Abbreviated | 01/25/2001SE |
| K001492 | Quinton Q-Stress, Model 000483DPS · Abbreviated | 08/09/2000SE |
| K992908 | Q-Tel Telemetry System V. 6.0 (ST)DSI · Traditional | 03/06/2000SE |
| K990866 | Quinton Medtrack CR Plus TreadmillISD · Traditional | 04/29/1999SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | 08/25/1997SE |
| K964784 | Synergy Cardiology Information System (00431)DPS · Traditional | 08/13/1997SE |
| K964978 | Vital Statistics System (O-Cath Accessory)DQA · Traditional | 05/21/1997SE |
| K955002 | Mahurkar 8 FR Dual Lemen CatheterMPB · Traditional | 09/13/1996SE |
| K961014 | Quinton Model Q710 Exercise and Resting ElectrocardiographLOS · Traditional | 07/31/1996SE |
Questions and answers
When was Quinton Q-Cath, Model 000460 cleared by the FDA?
Quinton Q-Cath, Model 000460 (K021906) received a 510(k) decision of Substantially Equivalent on September 4, 2002, 86 days after the submission was received.
What is the product code of K021906?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.