Cleared Traditional

K903927 - LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

K903927 is an FDA 510(k) clearance for LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, manufactured by Biotronik, GmbH & Co.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K903927 · Biotronik, GmbH & Co. · Cardiovascular device
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Oct 1990
Decision
57d
Days
Class 3
Risk

K903927 is an FDA 510(k) clearance for the LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, GmbH & Co. (Lake Oswego, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 57 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 Biotronik, GmbH & Co. devices

FDA 510(k) Submission Details - K903927

510(k) Number K903927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date October 16, 1990
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
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 420
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K903927.
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672 · Intermedics, Inc. · Mar 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741 · Telectronics Pacing Systems, Inc. · Jan 1991
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
K903221 · Telectronics Pacing Systems, Inc. · Nov 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
K903928 · Biotronik, GmbH & Co. · Oct 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929 · Biotronik, GmbH & Co. · Oct 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002 · Medtronic Vascular · Sep 1990