Cleared Traditional

K811350 - UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.

K811350 is the FDA 510(k) clearance for UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K811350 · Medtronic Vascular · Cardiovascular device
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Jul 1981
Decision
49d
Days
Class 3
Risk

K811350 is an FDA 510(k) clearance for the UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 49 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 Medtronic Vascular devices

Submission Details

510(k) Number K811350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1981
Decision Date July 01, 1981
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K811350.
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402 · Cardiac Pacemakers, Inc. · Jul 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887 · Ela Medical, Inc. · Jul 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691 · Cordis Corp. · Jul 1981
#325 PROGRAMMABLE CARD. PULSE GENERATOR
K810884 · Cook Pacemaker Corp. · Jun 1981
#326 PROGRAMMABLE CARD. PULSE GENERATOR
K810885 · Cook Pacemaker Corp. · Jun 1981
ELA MEDICAL UNILITH PULSE GENERATOR
K810142 · Ela Medical, Inc. · May 1981