Cleared Traditional

K801763 - VIVALITH 5

K801763 is the FDA 510(k) clearance for VIVALITH 5 by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K801763 · Pacesetter Systems · Cardiovascular device
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Aug 1980
Decision
30d
Days
Class 3
Risk

K801763 is an FDA 510(k) clearance for the VIVALITH 5, - MDL-201A & TDL-201A. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 30 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 K801763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 27, 1980
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K801763.
MEDTRONIC MODEL 2409
K800226 · Medtronic Vascular · Sep 1980
INSULATING SHEATH
K801910 · Cordis Corp. · Sep 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · Intermedics, Inc. · Sep 1980
INTERMEDICS THIN LITH IV SERIES UNIPOLAR
K801450 · Intermedics, Inc. · Aug 1980
MULTICOR (GAMMA) MODEL 336 & MODEL 337
K801106 · Cordis Corp. · Jul 1980
MICROTHIN-P1 (MOD. 0622)
K801121 · Cardiac Pacemakers, Inc. · Jun 1980