Cleared Traditional

K792321 - IMPLANTABLE END. MUSH. TIP LEADS030-224

K792321 is an FDA 510(k) clearance for IMPLANTABLE END. MUSH. TIP LEADS030-224, manufactured by Telectronics, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K792321 · Telectronics, Inc. · Cardiovascular device
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Dec 1979
Decision
24d
Days
Class 3
Risk

K792321 is an FDA 510(k) clearance for the IMPLANTABLE END. MUSH. TIP LEADS030-224. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1979 after a review of 24 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 Telectronics, Inc. devices

FDA 510(k) Submission Details - K792321

510(k) Number K792321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1979
Decision Date December 13, 1979
Days to Decision 24 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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

DTB Device Classification - Class 3, Premarket Approval

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 387
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K792321.
LEAD, SUTURELESS MYOCARDIAL
K800355 · Daig Corp. · May 1980
RESTERILIZATION OF IMPLANTABLE ELECTRODE
K800891 · Telectronics, Inc. · May 1980
LIFELINE TLE ENDOCARDIAL PACING LEAD,
K792604 · Intermedics, Inc. · Dec 1979
IMPLANTABLE ENDOCARDIAL TINED ELECTRODE
K792387 · Telectronics, Inc. · Dec 1979
LIFELINE - ENDOCARDIAL PACING LEAD
K792168 · Intermedics, Inc. · Nov 1979
CORDIS PERMANENT PERVENOUS CARDIAC LEADS
K791768 · Cordis Corp. · Nov 1979