PV-LAB Model PVL-1 Peripheral Vascular System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K871912 ↗

FDA Product Code

DPT

Device Class

Class II

Regulation

21 CFR Part 870.2120

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Bilateral Impedance Plethysmograph, Bip(Tm)

  Class II

  FDA 510(k) K862714 Active Cleared 17 Nov 1986

• Vasograph, Model Mv-2

  Class II

  FDA 510(k) K822455 Active Cleared 24 Sep 1982

• Model Ipm-1 Impedance Pulse Monitor

  Class II

  FDA 510(k) K932438 Active Cleared 3 Dec 1993

• What clinical scenarios is the PV-LAB Model PVL-1 primarily used for, and how does it function in those settings?

  The PV-LAB Model PVL-1 is designed for extravascular peripheral vascular assessment, specifically to measure blood flow dynamics in peripheral arteries. Clinicians use it to evaluate vascular function as part of diagnostic evaluations for peripheral artery disease (PAD). It operates alongside complementary systems like air plethysmography, Doppler, or photoplethysmography (PPG) to assess segmental arterial function, helping determine blood flow restrictions or occlusions in limbs.

• Is the PV-LAB Model PVL-1 a single-use or reusable device, and what maintenance considerations should be noted?

  The PV-LAB Model PVL-1 is reusable, intended for use in clinical settings like cardiovascular laboratories. Since it lacks specific sterility requirements in the provided data, proper cleaning and maintenance protocols (e.g., disinfection between patients) should follow manufacturer guidelines to ensure accuracy and longevity. Reusability aligns with its design as a diagnostic tool for repeated use in vascular assessments.

• What regulatory pathway was followed for FDA clearance of the PV-LAB Model PVL-1, and what does that mean for its use?

  The PV-LAB Model PVL-1 received FDA 510(k) clearance (K871912) under a traditional review pathway, classified as a Class II device with a substantially equivalent determination to a predicate device. This means it was deemed comparable to an existing approved device in terms of safety and effectiveness for its intended use—extravascular blood-flow measurement in peripheral arteries—and is authorized for use in clinical settings adhering to cardiovascular diagnostic standards.

• Are there any size or model variations for the PV-LAB Model PVL-1, or is it a single standardized probe?

  The provided data only references the PV-LAB Model PVL-1 as a single standardized device, without mentioning alternative sizes or models. It is described as a blood-flow probe for peripheral vascular assessment, implying a uniform design for measuring arterial dynamics. For specific probe dimensions or technical specifications, refer to the manufacturer’s documentation.