Cleared Traditional

K833098 - BIOTRONIK DN UNIPOLAR PE-60/4-DN &

K833098 is an FDA 510(k) clearance for BIOTRONIK DN UNIPOLAR PE-60/4-DN &, manufactured by Biotronik Sales, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K833098 · Biotronik Sales, Inc. · Cardiovascular device
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Oct 1983
Decision
37d
Days
Class 3
Risk

K833098 is an FDA 510(k) clearance for the BIOTRONIK DN UNIPOLAR PE-60/4-DN &. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 37 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 Sales, Inc. devices

FDA 510(k) Submission Details - K833098

510(k) Number K833098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date October 19, 1983
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K833098.
PERMANTHANE #866 BIPOLAR COAXIAL
K832987 · Pacesetter Systems · Oct 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104 · Biotronik Sales, Inc. · Oct 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108 · Biotronik Sales, Inc. · Oct 1983