Cleared Special

K001413 - ELOX 45-BP

K001413 is the FDA 510(k) clearance for ELOX 45-BP by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Special 510(k) pathway after a 29-day FDA review.

K001413 · Biotronik, Inc. · Cardiovascular device
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Jun 2000
Decision
29d
Days
Class 3
Risk

K001413 is an FDA 510(k) clearance for the ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668. 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 June 2, 2000 after a review of 29 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 K001413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received May 04, 2000
Decision Date June 02, 2000
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K001413.
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
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · Biotronik, Inc. · Jan 2001
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
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
K000029 · Ela Medical, Inc. · Apr 2000