Cleared Traditional

K883070 - ENCOR UNIPOLAR VS-1 LEADS

K883070 is an FDA 510(k) clearance for ENCOR UNIPOLAR VS-1 LEADS, manufactured by Cordis Leads, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K883070 · Cordis Leads, Inc. · Cardiovascular device
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Dec 1988
Decision
138d
Days
Class 3
Risk

K883070 is an FDA 510(k) clearance for the ENCOR UNIPOLAR VS-1 LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Cordis Leads, Inc. (Englewood, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 138 days - within the typical 510(k) review window.

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 Cordis Leads, Inc. devices

FDA 510(k) Submission Details - K883070

510(k) Number K883070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1988
Decision Date December 05, 1988
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
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 K883070.
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · Medtronic Vascular · Jan 1989
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
K884278 · Telectronics, Inc. · Dec 1988
PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
K884394 · Ela Medical, Inc. · Dec 1988
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