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K Number
K971281
Device Name
RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
Manufacturer
MEDCOMP
Date Cleared
1997-10-09

(185 days)

Product Code
DQX
Regulation Number
870.1330
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K043446
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

THE MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE IS DESIGNED FOR GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT. IT IS INSERTED PERCUTANEOUSLY. IT IS INTENDED TO BE INSERTED BY QUALIFIED, EXPERIENCED PHYSICIANS ONLY. THIS PRODUCT IS NOT MEANT TO BE USED FOR ANY PURPOSE OTHER THAN THAT WHICH IS INDICATED ABOVE.

Device Description

Not Found

AI/ML Overview

I'm sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device (Raulerson® One-Step Guidewire Insertion Bulb Needle) and primarily discusses regulatory compliance and marketing authorization. It does not include details about device performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.