Cleared Traditional

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM (K111603) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111603 · Ep Dynamics, Inc. · Cardiovascular device
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Aug 2012
Decision
442d
Days
Class 2
Risk

K111603 is an FDA 510(k) clearance for the LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Ep Dynamics, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Ep Dynamics, Inc. devices

Submission Details

510(k) Number K111603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2011
Decision Date August 23, 2012
Days to Decision 442 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
317d slower than avg
Panel avg: 125d · This submission: 442d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 701
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