Search Results
Found 1 results
510(k) Data Aggregation
K Number
K203803Device Name
VASOBand Vascular Compression Device
Manufacturer
Date Cleared
2021-01-26
(29 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
VASOInnovations, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VASOBandTM is a compression device to assist patent hemostasis of the radial artery after a transradial procedure.
Device Description
The VASOBand™ Vascular Compression Device is an external compression device to promote patent radial artery hemostasis after a transradial procedure. The VASOBand™ Vascular Compression Device is an external compression device used on a human arm and provides a means for a healthcare professional to apply external compression proximal to and/or over a catheterization puncture site for the purpose of assisting post-procedure patent hemostasis at a target vessel's puncture site. Each device is a single-use, sterile, individually pouched inflatable band. The VASOBand™ Vascular Compression Device is available in two different lengths. The strap measures approximately 26 cm or 29 cm in length and is composed of biocompatible multiple-layer PVC film and PVC tubing, and valves made of biocompatible thermoplastics. Hook and loop materials are used to secure the strap in position. Only the biocompatible thermoplastic film comes into contact with broken skin. The user can control the compression applied by the device by introducing or removing air in a bladder of the device.
Ask a Question
Ask a specific question about this device
Page 1 of 1