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K Number
K072130
Device Name
PTFE PEEL AWAY MICROINTRODUCER
Manufacturer
INTROMED
Date Cleared
2007-10-31

(90 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

PTFE Peel Away Microintroducer

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study. It is a letter from the FDA regarding a 510(k) premarket notification for a medical device called "PTFE Peel Away Microintroducer," confirming its substantial equivalence to a legally marketed predicate device. This letter primarily focuses on regulatory compliance and does not detail any technical performance studies performed on the device.

§ 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).