Cleared Traditional

K860548 - MODEL 492-02 ENDOCARDIAL PACING LEAD

K860548 is an FDA 510(k) clearance for MODEL 492-02 ENDOCARDIAL PACING LEAD, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K860548 · Intermedics, Inc. · Cardiovascular device
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Jun 1986
Decision
120d
Days
Class 3
Risk

K860548 is an FDA 510(k) clearance for the MODEL 492-02 ENDOCARDIAL 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 June 13, 1986 after a review of 120 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K860548

510(k) Number K860548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1986
Decision Date June 13, 1986
Days to Decision 120 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
5d faster than avg
Panel avg: 125d · This submission: 120d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K860548.
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD
K862276 · Intermedics, Inc. · Jul 1986
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846 · Cordis Corp. · Jun 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547 · Intermedics, Inc. · Jun 1986
ENDOCARDIAL CARBON-TIP LEAD
K861481 · Pacesetter Systems · Jun 1986
LEAD BODY CHANGES TO HI PERFORM & FAST-PASS LEADS
K861464 · Pacesetter Systems · May 1986
LEADS UTILIZ VOLUN STAND #1 3.2 MM UNI/BIOPOLAR CO
K861440 · Pacesetter Systems · May 1986