Cleared Traditional

K791316 - MEDTRONIC MODELS 5984/5985

K791316 is an FDA 510(k) clearance for MEDTRONIC MODELS 5984/5985, manufactured by Medtronic Vascular. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K791316 · Medtronic Vascular · Cardiovascular device
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Nov 1979
Decision
126d
Days
Class 3
Risk

K791316 is an FDA 510(k) clearance for the MEDTRONIC MODELS 5984/5985. 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 November 15, 1979 after a review of 126 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K791316

510(k) Number K791316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date November 15, 1979
Days to Decision 126 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
1d slower than avg
Panel avg: 125d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

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 393
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791316.
CARDIAC PACEMAKER P4000 SER. & P1000
K791920 · Vitatron Medical BV · Nov 1979
ARCOLITH 2100-CARDIAC PULSE GENERATOR
K792216 · Arco Medical Products Co. · Nov 1979
ARCOLITH 3020-CARDIAC PULSE GENERATOR
K792299 · Arco Medical Products Co. · Nov 1979
CARDIAC PACEMAKER C4000, C1000 SER.
K791921 · Vitatron Medical BV · Oct 1979
OMNI-STANICOR (THETA) MOD 237A
K791783 · Cordis Corp. · Oct 1979
IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD
K792052 · Telectronics, Inc. · Oct 1979