Cleared Traditional

K041269 - ATRIUM MEDICAL CORPORATION ICAST COVERE...

K041269 is an FDA 510(k) clearance for ATRIUM MEDICAL CORPORATION ICAST COVERE..., manufactured by Atrium Medical Corp.. The device is a Class 2 General & Plastic Surgery device with product code JCT cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K041269 · Atrium Medical Corp. · General & Plastic Surgery device
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Sep 2004
Decision
125d
Days
Class 2
Risk

K041269 is an FDA 510(k) clearance for the ATRIUM MEDICAL CORPORATION ICAST COVERED STENT. Classified as Prosthesis, Tracheal, Expandable (product code JCT), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on September 14, 2004 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3720 - the FDA general and plastic surgery device 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K041269

510(k) Number K041269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date September 14, 2004
Days to Decision 125 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCT Device Classification - Class 2, Special Controls

Product Code JCT Prosthesis, Tracheal, Expandable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3720
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCT Prosthesis, Tracheal, Expandable

All 29
Devices cleared under the same product code (JCT) and FDA review panel - the closest regulatory comparables to K041269.
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
K121048 · Boston Scientific Corp · Aug 2012
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
K050832 · Bard Peripheral Vascular, Inc. · Jul 2005
ATRIUM ICAST COVERED STENT
K050814 · Atrium Medical Corp. · May 2005
VIATORR ENDOPROSTHESIS
K024178 · W.L. Gore & Associates, Inc. · Mar 2003
MODIFICATION TO VIABAHN ENDOPROSTHESIS
K023811 · W.L. Gore & Associates, Inc. · Dec 2002
WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
K021901 · Boston Scientific Scimed, Inc. · Jul 2002