Flat Vascular Probe
FDA 510(k) K896613 · Imex Medical Systems, Inc.
510(k) numberK896613
Submission
- Device name
- Flat Vascular Probe
- Applicant
- Imex Medical Systems, Inc.
Golden, CO, US - Received
- November 21, 1989
- Decision date
- February 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K260700 | BlueDop Vascular ExpertDPW · Traditional | BlueDop Medical, Ltd. | 07/08/2026SE |
| 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 |
|---|---|---|
| K973556 | Imex Medical Systems, Inc. Imexlab 9000IYN · Traditional | 04/24/1998SE |
| K973562 | Imex Medical Systems, Inc. Imexlab 9100IYN · Traditional | 04/15/1998SE |
| K973336 | Imex StethodopJAF · Traditional | 02/05/1998SE |
| K970156 | Imex Futuraldop ProIYO · Traditional | 04/04/1997SE |
| K942243 | Imex 8000 Personal Cascular LabIYO · Traditional | 11/03/1995SE |
| K944196 | Imwxdop IrJAF · Traditional | 05/12/1995SE |
| K942441 | Imexdop Ct+JAF · Traditional | 08/23/1994SE |
| K910462 | Pocket Dop 3HEP · Traditional | 06/24/1991SE |
| K901593 | Imex Dop-Tone IIKNG · Traditional | 07/02/1990SE |
| K882138 | Imexlab 3000 Vascular Diagnostic RecorderDPW · Traditional | 11/07/1988SE |
Questions and answers
When was Flat Vascular Probe cleared by the FDA?
Flat Vascular Probe (K896613) received a 510(k) decision of Substantially Equivalent on February 16, 1990, 87 days after the submission was received.
What is the product code of K896613?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.