VELCOM-100
FDA 510(k) K863210 · Waters Instruments, Inc.
510(k) numberK863210
Submission
- Device name
- VELCOM-100
- Applicant
- Waters Instruments, Inc.
Rochester, MN, US - Received
- August 20, 1986
- Decision date
- November 26, 1986
- 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 |
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| 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 |
|---|---|---|
| K053169 | RM3 Renal Preservation SystemKDK · Special | 01/17/2006SE |
| K042224 | RM3 Renal Preservation SystemKDN · Special | 10/22/2004SE |
| K971571 | RM3 Renal Preservation System--Control UnitKDN · Traditional | 07/29/1997SE |
| K921519 | OXICOM-2100DQA · Traditional | 10/23/1992SE |
| K911207 | OxicomplusDQA · Traditional | 08/26/1991SE |
| K862161 | OSC-80 OximeterDQA · Traditional | 08/18/1986SE |
| K852909 | MVP - 6000BZC · Traditional | 11/14/1985SE |
| K834408 | TX-2 Thermal Dilution Cardiac OutputDXG · Traditional | 08/23/1984SE |
| K841876 | Polyurethane Thermal Dilution CathetDYG · Traditional | 07/13/1984SE |
| K813585 | Waters Ileostomy ValveKNT · Traditional | 04/09/1982SE |
Questions and answers
When was VELCOM-100 cleared by the FDA?
VELCOM-100 (K863210) received a 510(k) decision of Substantially Equivalent on November 26, 1986, 98 days after the submission was received.
What is the product code of K863210?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.