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K Number
K990308
Device Name
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
Manufacturer
ROCAP DIV. OF SABRATEK CORP.
Date Cleared
1999-12-10

(312 days)

Product Code
FOZ
Regulation Number
880.5200
Type
Traditional
Panel
HO
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ROCAP Heparin Flush Syringe 100 U/mL is indicated for use to maintain patency of indwelling venous access devices.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Heparin IV Flush Syringe). It does not contain information on acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. This type of information is usually found in a separate study report or regulatory submission document.

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).