Cleared Traditional

IMPLANTABLE ADAPTOR 033-380

K890895 · Telectronics, Inc. · Cardiovascular
Mar 1990
Decision
377d
Days
Class 2
Risk

About This 510(k) Submission

K890895 is an FDA 510(k) clearance for the IMPLANTABLE ADAPTOR 033-380, a Pacemaker Lead Adaptor (Class II — Special Controls, product code DTD), submitted by Telectronics, Inc. (Englewood, US). The FDA issued a Cleared decision on March 6, 1990, 377 days after receiving the submission on February 22, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3620.

Submission Details

510(k) Number K890895 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1989
Decision Date March 06, 1990
Days to Decision 377 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTD — Pacemaker Lead Adaptor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3620

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