Cleared Traditional

K803042 - SIEMENS-ELEMA ENDOCARDIAL LEAD 402S

K803042 is an FDA 510(k) clearance for SIEMENS-ELEMA ENDOCARDIAL LEAD 402S, manufactured by Siemens Elema AB. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K803042 · Siemens Elema AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1980
Decision
21d
Days
Class 3
Risk

K803042 is an FDA 510(k) clearance for the SIEMENS-ELEMA ENDOCARDIAL LEAD 402S. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 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 Siemens Elema AB devices

FDA 510(k) Submission Details - K803042

510(k) Number K803042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1980
Decision Date December 22, 1980
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.

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 K803042.
ENDOCARDIAL LEADS 414S & 515S
K802816 · Siemens Elema AB · Jan 1981
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS
K802413 · Telectronics, Inc. · Jan 1981
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC
K802968 · Telectronics, Inc. · Dec 1980
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · Intermedics, Inc. · Dec 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284 · Medtronic Vascular · Dec 1980
MEDTRONIC MODEL 6958
K800870 · Medtronic Vascular · Nov 1980