Cleared Traditional

CARDIAC PACEMAKER S6001 (K772009) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K772009 · Vitatron Medical BV · Cardiovascular device
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Nov 1977
Decision
34d
Days
Class 3
Risk

K772009 is an FDA 510(k) clearance for the CARDIAC PACEMAKER S6001. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Vitatron Medical BV (Mchenry, US). The FDA issued a Cleared decision on November 28, 1977 after a review of 34 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 Vitatron Medical BV devices

Submission Details

510(k) Number K772009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1977
Decision Date November 28, 1977
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
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 135
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K772009.
XYREL-RA MODELS 5994/5995
K771770 · Medtronic Vascular · Jan 1978
CARDIAC PULSE GENERATORS 5982/5983
K771786 · Medtronic Vascular · Jan 1978
PULSE GENERATOR, A-V SEQ.
K772202 · Medtronic Vascular · Dec 1977
BIPOLAR PACEMAKER MODEL 224
K772057 · Intermedics, Inc. · Nov 1977
PACEMAKER MODEL 251
K771626 · Intermedics, Inc. · Sep 1977
CARDIAC PACERS W/NARROW PULSE WIDTH
K770951 · Cordis Corp. · Jun 1977