Cleared Traditional

K883930 - SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY

K883930 is an FDA 510(k) clearance for SEAMED MODEL 3300 DUAL CHAMBER PACING S..., manufactured by Seamed Corp.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K883930 · Seamed Corp. · Cardiovascular device
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Nov 1988
Decision
55d
Days
Class 2
Risk

K883930 is an FDA 510(k) clearance for the SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Seamed Corp. (Bothell, US). The FDA issued a Cleared decision on November 9, 1988 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Seamed Corp. devices

FDA 510(k) Submission Details - K883930

510(k) Number K883930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date November 09, 1988
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 51
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