Cleared Traditional

K791093 - MODELS 2411/2418 VENTRICULAR-INHIBITED

K791093 is the FDA 510(k) clearance for MODELS 2411/2418 VENTRICULAR-INHIBITED by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K791093 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1979
Decision
8d
Days
Class 3
Risk

K791093 is an FDA 510(k) clearance for the MODELS 2411/2418 VENTRICULAR-INHIBITED. 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 June 20, 1979 after a review of 8 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 K791093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date June 20, 1979
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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 K791093.
UNILITH PULSE GENERATOR
K791219 · Ela Medical, Inc. · Jul 1979
PULSE GENERATOR, MODEL 171
K782161 · Telectronics, Inc. · Jul 1979
BATTERY CHARGER, 171 PACEMAKER
K782162 · Telectronics, Inc. · Jul 1979
CARDIAC PULSE GENERATOR, 16 SERIES
K790867 · Telectronics, Inc. · May 1979
GENERATOR, 16 SERIES, MODIFIED TOP CAP
K790868 · Telectronics, Inc. · May 1979
OMNI-STANICOR-(THETA) MODEL 217
K790690 · Cordis Corp. · May 1979