Cleared Special

K023803 - MODIFICATION TO BIOTRONIK'S STERILIZATI...

K023803 is the FDA 510(k) clearance for MODIFICATION TO BIOTRONIK'S STERILIZATI... by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Special 510(k) pathway after a 27-day FDA review.

K023803 · Biotronik, Inc. · Cardiovascular device
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Dec 2002
Decision
27d
Days
Class 3
Risk

K023803 is an FDA 510(k) clearance for the MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on December 11, 2002 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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, Inc. devices

Submission Details

510(k) Number K023803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2002
Decision Date December 11, 2002
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 352
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K023803.
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular · May 2003
ELOX P 45-BP
K023205 · Biotronik, Inc. · Apr 2003
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB
K024053 · Oscor, Inc. · Jan 2003
AROX 45-JBP
K023099 · Biotronik, Inc. · Oct 2002
AROX 53-BP
K021217 · Biotronik, Inc. · May 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · Biotronik, Inc. · Apr 2002