Cleared Traditional

K883174 - MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE (FDA 510(k) Clearance)

Oct 1988
Decision
79d
Days
Class 2
Risk

K883174 is an FDA 510(k) clearance for the MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on October 14, 1988, 79 days after receiving the submission on July 27, 1988.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K883174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1988
Decision Date October 14, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1250

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