Cleared Traditional

K790261 - MEDTRONIC TEMPTRON

K790261 is the FDA 510(k) clearance for MEDTRONIC TEMPTRON by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K790261 · Medtronic Vascular · Cardiovascular device
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Feb 1979
Decision
21d
Days
Class 3
Risk

K790261 is an FDA 510(k) clearance for the MEDTRONIC TEMPTRON. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on February 27, 1979 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 K790261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1979
Decision Date February 27, 1979
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
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 - DTB Permanent Pacemaker Electrode

All 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K790261.
MEDTRONIC MODEL 6972
K790462 · Medtronic Vascular · Apr 1979
LEAD MODELS MUM 1260, MUM 1290
K790386 · Ela Medical, Inc. · Apr 1979
MEDTRONIC MODEL 6971
K790074 · Medtronic Vascular · Mar 1979
LIFELINE PACING LEAD MODEL 465-01
K781497 · Intermedics, Inc. · Feb 1979
LIFELINE BIPOLAR PACING LEAD MOD. 466-01
K781498 · Intermedics, Inc. · Feb 1979
LIFELINE PACING LEAD MODEL 467-01
K781499 · Intermedics, Inc. · Feb 1979