Cleared Traditional

MICRO TRANSDUCER CATHETERS

K813125 · Honeywell, Inc. · Cardiovascular
Dec 1981
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K813125 is an FDA 510(k) clearance for the MICRO TRANSDUCER CATHETERS, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1981, 40 days after receiving the submission on November 4, 1981. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K813125 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1981
Decision Date December 14, 1981
Days to Decision 40 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRE — Dilator, Vessel, For Percutaneous Catheterization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1310

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