Model PV2000 Vascular Microlaboratory

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K951486 ↗

FDA Product Code

DPW

Device Class

Class II

Regulation

21 CFR Part 870.2100

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modif. Laserflo Blood Perfusion Monitor Model BPM2

  Class II

  FDA 510(k) K912446 Active Cleared 12 Dec 1991

• Laserflo(R) Blood Perfusion Monitor (Model BPM2)

  Class II

  FDA 510(k) K911763 Active Cleared 13 Aug 1991

• Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe Kit

  Class II

  FDA 510(k) K962700 Active Cleared 9 Apr 1997

• Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433

  Class II

  FDA 510(k) K951832 Active Cleared 21 Mar 1996

• Trimflo Parenchymal Blood Flow Monitoring Probe Kit

  Class II

  FDA 510(k) K961368 Active Cleared 11 Oct 1996

• What is the primary use of the PV2000 Vascular Microlaboratory?

  The PV2000 Vascular Microlaboratory is designed specifically for measuring and analyzing blood flow in microvascular studies. It provides critical data for assessing vascular function and perfusion, supporting both diagnostic and research applications in cardiology. This helps clinicians and researchers monitor blood flow dynamics with precision in controlled laboratory environments.

• Is the PV2000 Vascular Microlaboratory reusable or single-use?

  The PV2000 Vascular Microlaboratory is supplied as a reusable instrument. While it is not specified as sterile, it requires thorough cleaning and maintenance to ensure reliability and safety for repeated use in laboratory settings. Proper care is essential to maintain its performance and prevent contamination.

• Can the PV2000 Vascular Microlaboratory be used in an MRI environment?

  No, the PV2000 Vascular Microlaboratory is classified as MRI-unsafe. This means it should never be used in or near magnetic resonance imaging environments, as exposure to MRI fields could compromise the device’s integrity or pose safety risks to patients and staff.

• What regulatory approval does the PV2000 Vascular Microlaboratory hold?

  The PV2000 Vascular Microlaboratory is authorized under FDA 510(k) clearance with the reference number K951486. It is classified as a Class II medical device under product code DPW and falls within the Cardiovascular specialty. The device is regulated under FDA regulation 870.2100 and is considered substantially equivalent to predicate devices.

• What maintenance is required to ensure the PV2000’s reliability?

  Since the PV2000 is a reusable instrument, it requires proper cleaning and maintenance to ensure accuracy, reliability, and safety. Regular upkeep prevents contamination and wear, which could affect its performance in measuring blood flow. Follow the manufacturer’s guidelines for cleaning protocols and calibration to maintain optimal functionality.