Cleared Traditional

K791417 - IMPLANTABLE PULSE GENERATOR PACEMAKER

K791417 is an FDA 510(k) clearance for IMPLANTABLE PULSE GENERATOR PACEMAKER, manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K791417 · Intermedics, Inc. · Cardiovascular device
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Sep 1979
Decision
39d
Days
Class 3
Risk

K791417 is an FDA 510(k) clearance for the IMPLANTABLE PULSE GENERATOR PACEMAKER. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 39 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K791417

510(k) Number K791417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1979
Decision Date September 04, 1979
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 354
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K791417.
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K791181 · Medtronic Vascular · Sep 1979
IMPLANTABLE PULSE GENERATOR PACEMAKERS
K791568 · Intermedics, Inc. · Sep 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379 · Intermedics, Inc. · Sep 1979
PULSE GENERATOR, R WAVE DEMAND
K790141 · Pacesetter Systems · Aug 1979
MDL-201A & T DL-201A PULSE GENERATOR
K790428 · Pacesetter Systems · Aug 1979
BJORK-SHILEY AORTIC GRAFT VALVE PROSTH
K791225 · Shiley, Inc. · Aug 1979