Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
FDA 510(k) K172457 · Deltex Medical Limited
510(k) numberK172457
Submission
- Device name
- Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
- Applicant
- Deltex Medical Limited
Chichester, GB - Received
- August 14, 2017
- Decision date
- June 28, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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|---|---|---|---|
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| K252810 | FloPatch FP120DPW · Special | Flosonics Medical | 04/24/2026SE |
| K251904 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock…DPW · Traditional | Remington Medical, Inc. | 11/20/2025SE |
| K251114 | FloPatch FP120DPW · Traditional | Flosonics Medical | 06/20/2025SE |
| K243852 | Elfor-LDPW · Traditional | Elfi-Tech , Ltd. | 04/14/2025SE |
| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | Remington Medical, Inc. | 08/30/2024SE |
| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 01/27/2022SE |
More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+DPW · Traditional | 07/24/2015SE |
| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | 01/22/2015SE |
| K132139 | Deltex Medical Cardioq-Edm+DPW · Traditional | 10/10/2013SE |
| K111542 | Deltex Medical Cardioq EdmDPW · Traditional | 10/20/2011SE |
| K073593 | I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour)…DPT · Traditional | 01/29/2009SE |
| K052989 | DP240 240 Hour Doppler ProbeDPT · Traditional | 03/08/2006SE |
| K031706 | Cardioq, Model 9051-7005DPW · Traditional | 08/06/2003SE |
| K951369 | EdmDPW · Traditional | 11/07/1995SE |
Questions and answers
When was Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM cleared by the FDA?
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (K172457) received a 510(k) decision of Substantially Equivalent on June 28, 2018, 318 days after the submission was received.
What is the product code of K172457?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.