Model PV2000 Vascular Microlaboratory
FDA 510(k) K951486 · Vasamedics, LLC
510(k) numberK951486
Submission
- Device name
- Model PV2000 Vascular Microlaboratory
- Applicant
- Vasamedics, LLC
Saint Paul, MN, US - Received
- March 30, 1995
- Decision date
- June 29, 1995
- 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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| 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 |
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K962700 | Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring…DPT · Traditional | 04/09/1997SE |
| K961368 | Trimflo Parenchymal Blood Flow Monitoring Probe KitDPT · Traditional | 10/11/1996SESK |
| K951832 | Laserflo Blood Perfusion Single Use Probes Models SUP-440, SUPR-434 SUP-433DPT · Traditional | 03/21/1996SE |
| K912446 | Modif. Laserflo Blood Perfusion Monitor Model BPM2DPW · Traditional | 12/12/1991SE |
| K911763 | Laserflo(R) Blood Perfusion Monitor (Model BPM2)DPW · Traditional | 08/13/1991SE |
Questions and answers
When was Model PV2000 Vascular Microlaboratory cleared by the FDA?
Model PV2000 Vascular Microlaboratory (K951486) received a 510(k) decision of Substantially Equivalent on June 29, 1995, 91 days after the submission was received.
What is the product code of K951486?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.