NAVIGATOR-MP CATHETER LOCATION INSTRUMENT

K940385 · Navion Biomedical Corp. · FOZ · Jun 2, 1994 · General Hospital

Device Facts

Record IDK940385
Device NameNAVIGATOR-MP CATHETER LOCATION INSTRUMENT
ApplicantNavion Biomedical Corp.
Product CodeFOZ · General Hospital
Decision DateJun 2, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 880.5200
Device ClassClass 2

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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