Cleared Traditional

K860462 - SEAMED MODEL 3000

K860462 is an FDA 510(k) clearance for SEAMED MODEL 3000, manufactured by Seamed Corp.. The device is a Class 2 Cardiovascular device with product code DTC cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K860462 · Seamed Corp. · Cardiovascular device
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Aug 1986
Decision
194d
Days
Class 2
Risk

K860462 is an FDA 510(k) clearance for the SEAMED MODEL 3000. Classified as Analyzer, Pacemaker Generator Function (product code DTC), Class II - Special Controls.

Submitted by Seamed Corp. (Redmond, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 194 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3630 - 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: Standard predicate-based submission. Standard predicate reliance. 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 Seamed Corp. devices

FDA 510(k) Submission Details - K860462

510(k) Number K860462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1986
Decision Date August 19, 1986
Days to Decision 194 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
69d slower than avg
Panel avg: 125d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTC Device Classification - Class 2, Special Controls

Product Code DTC Analyzer, Pacemaker Generator Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3630
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTC Analyzer, Pacemaker Generator Function

All 24
Devices cleared under the same product code (DTC) and FDA review panel - the closest regulatory comparables to K860462.
MEDTRONIC MODEL 5401B TEST CABLE
K896632 · Medtronic Vascular · Dec 1989
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · Medtronic Vascular · Jan 1989
PACER SENSING ANALYZER (PSA 100)
K882327 · Oscor Medical Corp. · Oct 1988
SEA MED DDD PACING SYSTEM ANALYZER
K851900 · Seamed Corp. · Jul 1985
MEDTRONIC 5311 PACING SYSTEM ANALYZER
K850077 · Medtronic Vascular · Jul 1985
CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER)
K844969 · Cordis Corp. · May 1985