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K Number
K953564

Validate with FDA (Live)

Device Name
MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
Manufacturer
MEDTRONIC CARDIAC SURGERY, MEDTRONIC, INC.
Date Cleared
1996-02-02

(186 days)

Product Code
DTL
Regulation Number
870.4290
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K031700
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.