Cleared Traditional

K800226 - MEDTRONIC MODEL 2409

K800226 is the FDA 510(k) clearance for MEDTRONIC MODEL 2409 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K800226 · Medtronic Vascular · Cardiovascular device
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Sep 1980
Decision
217d
Days
Class 3
Risk

K800226 is an FDA 510(k) clearance for the MEDTRONIC MODEL 2409. 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 September 9, 1980 after a review of 217 days - an extended review 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 K800226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1980
Decision Date September 09, 1980
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
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 K800226.
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN
K802028 · Telectronics, Inc. · Sep 1980
IMPLANTABLE PROGRAM. CARDIAC PACEMAKER
K800793 · Telectronics, Inc. · Sep 1980
SIEMENS-ELEMA PULSE GENERATOR 625
K801508 · Siemens Elema AB · Sep 1980
INSULATING SHEATH
K801910 · Cordis Corp. · Sep 1980
BATTERY FOR #229-01 PULSE GENERATOR
K802040 · Intermedics, Inc. · Sep 1980
VIVALITH 5, - MDL-201A & TDL-201A
K801763 · Pacesetter Systems · Aug 1980