Cleared Traditional

K883313 - PMT VASCULAR CATHETER MODEL NUMBER 3621-1
(FDA 510(k) Clearance)

K883313 · Pmt Corp. · General Hospital
Oct 1988
Decision
60d
Days
Class 2
Risk

K883313 is an FDA 510(k) clearance for the PMT VASCULAR CATHETER MODEL NUMBER 3621-1. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS).

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on October 4, 1988, 60 days after receiving the submission on August 5, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K883313 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 1988
Decision Date October 04, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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