Cleared Traditional

K100799 - FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

K100799 is an FDA 510(k) clearance for FORTRESS INTRODUCER SHEATH SYSTEM MODEL..., manufactured by Contract Medical Intl. GmbH. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 340-day FDA review.

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

FDA 510(k) Submission Details - K100799

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.

DYB Device Classification - Class 2, Special Controls

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 498
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K100799.
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