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510(k) K002627

ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER by Atrium Medical Corp. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2001
Date Received
August 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

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  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

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