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510(k) Data Aggregation
K Number
K170958Device Name
ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
Manufacturer
Date Cleared
2017-08-29
(151 days)
Product Code
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Tricol Biomedical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ChitoPulse™ Radial Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's radial artery, including arterial or venous line or sheath removal, hemodialysis and in patients on anticoagulation therapy.
ChitoPulse™ Hemostatic Device is intended to promote hemostasis following a catheterization or other puncture into a blood vessel in a patient's leg, including dorsalis pedis or tibial blood vessels, arterial or venous line or sheath removal and in patients on anticoagulation therapy.
Device Description
ChitoPulse™ is a mechanical compression band incorporating a hemostatic chitosan patch. The compression band and chitosan patch are positioned over the radial access site and secured in place by a strap fastener. Addition of air to the compression band balloon provides rapid bleeding control by localized compression.
The chitosan patch provides adjunct bleeding control to the balloon compression and provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
Compression is applied or reduced using a syringe and luer lock valve to add or remove air volume to or from the balloon. Once hemostasis has been achieved, compression may be reduced by gradual removal of air from the balloon.
ChitoPulse™ is a single use device. Once hemostasis is achieved, the compression band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing for up to 24 hrs.
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