Cleared Special

K061212 - BIOTRONIK ENDOCARDIAL PACING LEADS

K061212 is the FDA 510(k) clearance for BIOTRONIK ENDOCARDIAL PACING LEADS by Biotronik, Inc.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Special 510(k) pathway after a 70-day FDA review.

K061212 · Biotronik, Inc. · Cardiovascular device
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Jul 2006
Decision
70d
Days
Class 3
Risk

K061212 is an FDA 510(k) clearance for the BIOTRONIK ENDOCARDIAL PACING LEADS. 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 July 10, 2006 after a review of 70 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 K061212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date July 10, 2006
Days to Decision 70 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
55d faster than avg
Panel avg: 125d · This submission: 70d
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 K061212.
PERMANENT PACING LEAD, MODEL PY2
K041809 · Oscor, Inc. · Aug 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
K040569 · Oscor, Inc. · Apr 2004
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
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
K023803 · Biotronik, Inc. · Dec 2002