LogoFDA 510(k) Search
K Number
K964238
Device Name
AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS
Manufacturer
AIRCAST, INC.
Date Cleared
1997-09-08

(320 days)

Product Code
JOW
Regulation Number
870.5800
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Same as the predicate device. The cuff is a part of the VenaFlow System. Indication for use is as a prophylaxis for DVT (Deep Vein Thrombosis).

Device Description

Aircast Venaflow Sterile Disposable Cuff

AI/ML Overview

This is a 510(k) approval letter for a medical device (AIRCAST Sterile VenaFlow™ Disposable Cuff) and does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria. The provided text is a regulatory document confirming substantial equivalence, not a study report.

Therefore, I cannot extract the requested information from the given text. It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, or details about test sets.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Training set sample size.
  9. How ground truth for the training set was established.

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).