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K Number
K972654
Device Name
MANIFOLD
Manufacturer
MEDICAL SPECIALTIES INTL., INC.
Date Cleared
1997-10-08

(85 days)

Product Code
DTL
Regulation Number
870.4290
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use is to direct the flow of fluids, via the stopcock arrangement, into tubing, catheters and collection systems during a heart catheterization procedure.

Device Description

Manifold

AI/ML Overview

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "Manifold", indicating its substantial equivalence to a predicate device. It briefly mentions the intended use, but there are no details about specific performance metrics, clinical studies, sample sizes, expert qualifications, or ground truth establishment.

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.