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510(k) K020634

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2002
Date Received
February 27, 2002
Clearance Type
Special
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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