Cleared Traditional

K834533 - ELECTRODE LEAD CONSTRUCTION

K834533 is an FDA 510(k) clearance for ELECTRODE LEAD CONSTRUCTION, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K834533 · Telectronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
39d
Days
Class 3
Risk

K834533 is an FDA 510(k) clearance for the ELECTRODE LEAD CONSTRUCTION. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Telectronics, Inc. devices

FDA 510(k) Submission Details - K834533

510(k) Number K834533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1983
Decision Date January 30, 1984
Days to Decision 39 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K834533.
LIFELINE TLE 476-04
K843393 · Intermedics, Inc. · Sep 1984
LIFELINE TLE 484-02
K843394 · Intermedics, Inc. · Sep 1984
PACING ELECTRODE
K834431 · Pacesetter Systems · Mar 1984
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · Pacesetter Systems · Dec 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997 · Oscor, Inc. · Oct 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · Pacesetter Systems · Oct 1983