Cleared Traditional

K896824 - BIOTRONIK'S PS-ENDOCARDIAL LEADS

K896824 is an FDA 510(k) clearance for BIOTRONIK'S PS-ENDOCARDIAL LEADS, 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 247-day FDA review.

K896824 · Biotronik, GmbH & Co. · Cardiovascular device
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Aug 1990
Decision
247d
Days
Class 3
Risk

K896824 is an FDA 510(k) clearance for the BIOTRONIK'S PS-ENDOCARDIAL LEADS. 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 August 8, 1990 after a review of 247 days - an extended review 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 - K896824

510(k) Number K896824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date August 08, 1990
Days to Decision 247 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
122d slower than avg
Panel avg: 125d · This submission: 247d
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 K896824.
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
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645 · Telectronics Pacing Systems, Inc. · Aug 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742 · Ela Medical, Inc. · Jul 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147 · Pacesetter Systems · Jul 1990