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K Number
K960143
Device Name
G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY
Manufacturer
GE MEDICAL SYSTEMS
Date Cleared
1996-04-09

(84 days)

Product Code
DWS
Regulation Number
870.4500
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.4500 Cardiovascular surgical instruments.

(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general 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.