Cleared Traditional

K803034 - MICROTHIN-PII BIPOLAR PULSE GEN. #0623

K803034 is the FDA 510(k) clearance for MICROTHIN-PII BIPOLAR PULSE GEN. #0623 by Cardiac Pacemakers, Inc.. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K803034 · Cardiac Pacemakers, Inc. · Cardiovascular device
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Dec 1980
Decision
21d
Days
Class 3
Risk

K803034 is an FDA 510(k) clearance for the MICROTHIN-PII BIPOLAR PULSE GEN. #0623. 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 December 22, 1980 after a review of 21 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 K803034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date December 22, 1980
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
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 K803034.
CYBERLITH PROGRAMMER
K801338 · Intermedics, Inc. · Jan 1981
MICRO THIN-DII, #0521
K802352 · Cardiac Pacemakers, Inc. · Dec 1980
MICRO THIN-PII, #0523
K802353 · 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-DI BIPOLAR PULSE GENERATOR
K802409 · Cardiac Pacemakers, Inc. · Oct 1980