Cleared Special

K050814 - ATRIUM ICAST COVERED STENT
(FDA 510(k) Clearance)

K050814 · Atrium Medical Corp. · General & Plastic Surgery

May 2005

Decision

36d

Days

Class 2

Risk

K050814 is an FDA 510(k) clearance for the ATRIUM ICAST COVERED STENT. This device is classified as a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT).

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on May 6, 2005, 36 days after receiving the submission on March 31, 2005.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number	K050814 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2005
Decision Date	May 06, 2005
Days to Decision	36 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Statement