Cleared Traditional

K883265 - MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD

K883265 is an FDA 510(k) clearance for MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD, manufactured by Telectronics and Cordis Pacing Systems. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K883265 · Telectronics and Cordis Pacing Systems · Cardiovascular device
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Oct 1988
Decision
74d
Days
Class 3
Risk

K883265 is an FDA 510(k) clearance for the MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics and Cordis Pacing Systems (Englewood, US). The FDA issued a Cleared decision on October 14, 1988 after a review of 74 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 and Cordis Pacing Systems devices

FDA 510(k) Submission Details - K883265

510(k) Number K883265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1988
Decision Date October 14, 1988
Days to Decision 74 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
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 424
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K883265.
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · Medtronic Vascular · Dec 1988
PERMANENT PACING LEADS PYBJ SERIES
K882345 · Oscor Medical Corp. · Oct 1988
PERMANENT PACING LEAD MODEL RXBJ SERIES
K882462 · Oscor Medical Corp. · Oct 1988
POLYSAFE(TM) IMPLANTABLE PACING LEAD
K884024 · Cardiac Control Systems, Inc. · Oct 1988
MEDTRONIC MODEL 4951P
K881810 · Medtronic Vascular · Oct 1988
POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
K883015 · Cardiac Control Systems, Inc. · Oct 1988