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K Number
K964518

Validate with FDA (Live)

Device Name
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
Manufacturer
DAIG CORP.
Date Cleared
1997-05-14

(201 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
Cardiovascular
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K022067,K040552,K042623,K043084,K052644,K061015,K181031,K212626,K983940
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).