Cleared Traditional

K802409 - MICROTHIN-DI BIPOLAR PULSE GENERATOR

K802409 is the FDA 510(k) clearance for MICROTHIN-DI BIPOLAR PULSE GENERATOR by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K802409 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Oct 1980
Decision
28d
Days
Class 3
Risk

K802409 is an FDA 510(k) clearance for the MICROTHIN-DI BIPOLAR PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Cardiac Pacemakers, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K802409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1980
Decision Date October 31, 1980
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 279
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K802409.
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · Cardiac Pacemakers, Inc. · Dec 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035 · Cardiac Pacemakers, Inc. · Dec 1980
SIEMENS-ELEMA PULSE GENERATOR 668
K801324 · Siemens Elema AB · Dec 1980
MICROTHIN-PI BIPOLAR PULSE GENERATOR
K802410 · Cardiac Pacemakers, Inc. · Oct 1980
SORIN PULSE GENERATOR, MODEL #LIT-214
K801640 · Bentley Laboratories, Inc. · Oct 1980
PROGRAMALITH #'S 221, 222, 221A & 222A
K801978 · Pacesetter Systems · Sep 1980