Cleared Traditional

K844334 - VIVALITH II 301 PULSE GENERATOR

K844334 is the FDA 510(k) clearance for VIVALITH II 301 PULSE GENERATOR by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K844334 · Pacesetter Systems · Cardiovascular device
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Jan 1985
Decision
64d
Days
Class 3
Risk

K844334 is an FDA 510(k) clearance for the VIVALITH II 301 PULSE GENERATOR. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 64 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 Pacesetter Systems devices

Submission Details

510(k) Number K844334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1984
Decision Date January 10, 1985
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
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 339
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K844334.
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
K844957 · Medtronic Vascular · Feb 1985
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
K844958 · Medtronic Vascular · Feb 1985
MULTILITH PULSE GENERATORS, 1141 & 2141
K842193 · Ela Medical, Inc. · Jan 1985
PULSE GENERATOR 689, 689B & 689L
K841225 · Siemens Elema AB · Dec 1984
PULSE GENERATOR 686, 686B 686L
K841230 · Siemens Elema AB · Dec 1984
PULSE GENERATOR 696, 696B & 696L
K841232 · Siemens Elema AB · Dec 1984