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K Number
K071225
Device Name
INNOVASA STAT*SEAL TOPICAL HEMOSTAT
Manufacturer
INNOVASA, INC.
Date Cleared
2007-08-31

(121 days)

Product Code
DXC
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.

Device Description

Trade Name, Stat*Seal Topical Hemostat

AI/ML Overview

This appears to be a 510(k) clearance letter from the FDA for a medical device called "Stat*Seal Topical Hemostat," indicating that it has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as requested in the prompt.

The letter is a regulatory approval document and does not detail the technical performance studies of the device. Therefore, I cannot extract the information required by the prompt from the provided text.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).