Cleared Traditional

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)

K890350 · Telectronics, Inc. · Cardiovascular
Feb 1989
Decision
86d
Days
Class 3
Risk

About This 510(k) Submission

K890350 is an FDA 510(k) clearance for the VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE), a Permanent Pacemaker Electrode (Class III — Premarket Approval, product code DTB), submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on February 2, 1989, 86 days after receiving the submission on November 8, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number K890350 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1988
Decision Date February 02, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTB — Permanent Pacemaker Electrode
Device Class Class III — Premarket Approval
CFR Regulation 21 CFR 870.3680

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