Cleared Traditional

K771750 - RF CHOKE CABLE (FDA 510(k) Clearance)

Sep 1977
Decision
15d
Days
Class 2
Risk

K771750 is an FDA 510(k) clearance for the RF CHOKE CABLE. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1977, 15 days after receiving the submission on September 15, 1977.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.

Submission Details

510(k) Number K771750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1977
Decision Date September 30, 1977
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary

Device Classification

Product Code DSA — Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2900