Cleared Traditional

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 (K100799) - FDA 510(k) Clearance

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

K100799 · Contract Medical Intl. GmbH · Cardiovascular device
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Feb 2011
Decision
340d
Days
Class 2
Risk

K100799 is an FDA 510(k) clearance for the FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Contract Medical Intl. GmbH (Dresden, Sachsen, DE). The FDA issued a Cleared decision on February 25, 2011 after a review of 340 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: Standard predicate-based submission. Elevated predicate reliance 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 Contract Medical Intl. GmbH devices

Submission Details

510(k) Number K100799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2010
Decision Date February 25, 2011
Days to Decision 340 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
215d slower than avg
Panel avg: 125d · This submission: 340d
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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