Cleared Traditional

K003072 - PACING LEADS

K003072 is the FDA 510(k) clearance for PACING LEADS by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K003072 · Biotronik, Inc. · Cardiovascular device
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Jan 2001
Decision
98d
Days
Class 3
Risk

K003072 is an FDA 510(k) clearance for the PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES. 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 January 9, 2001 after a review of 98 days - within the typical 510(k) review window.

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, Inc. devices

Submission Details

510(k) Number K003072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date January 09, 2001
Days to Decision 98 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

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 K003072.
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · Oscor, Inc. · Mar 2002
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · Oscor, Inc. · Nov 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · Oscor, Inc. · May 2001
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
K001413 · Biotronik, Inc. · Jun 2000
EX 45-BP, MODEL 330 132
K994240 · Biotronik, Inc. · Apr 2000
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K993448 · Ela Medical, Inc. · Apr 2000