Cleared Traditional

K813134 - ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP

K813134 is an FDA 510(k) clearance for ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP, 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 35-day FDA review.

K813134 · Telectronics, Inc. · Cardiovascular device
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Dec 1981
Decision
35d
Days
Class 3
Risk

K813134 is an FDA 510(k) clearance for the ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP. 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 10, 1981 after a review of 35 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 - K813134

510(k) Number K813134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1981
Decision Date December 10, 1981
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 K813134.
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121 · Telectronics, Inc. · Feb 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205 · Extracorporeal Medical Specialities, Inc. · Jan 1982
POLY-FLEX PACING LEADS
K813028 · Intermedics, Inc. · Dec 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139 · Pacesetter Systems · Nov 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286 · Pacesetter Systems · Nov 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989 · Intermedics, Inc. · Nov 1981