Cleared Traditional

BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD (K883602) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K883602 · Intermedics, Inc. · Cardiovascular device
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Sep 1988
Decision
14d
Days
Class 3
Risk

K883602 is an FDA 510(k) clearance for the BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on September 6, 1988 after a review of 14 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 Intermedics, Inc. devices

Submission Details

510(k) Number K883602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date September 06, 1988
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K883602.
ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
K884005 · Medtronic Vascular · Dec 1988
MEDTRONIC MODEL 4951P
K881810 · Medtronic Vascular · Oct 1988
MODEL 5866-34A PACEMAKER LEAD ADAPTOR
K883203 · Medtronic Vascular · Sep 1988
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
K882452 · Medtronic Vascular · Aug 1988
IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
K874664 · Telectronics, Inc. · May 1988
MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K875178 · Intermedics, Inc. · May 1988