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510(k) K002627

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

K002627 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on April 26, 2001. The device falls under product code DXE (Catheter, Embolectomy), a Class II device regulated under 21 CFR 870.5150. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.

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

Other clearances by Atrium Medical Corp.

  • K130131 — EDRAIN CHEST DRAINAGE SYSTEM (February 28, 2013)
  • K122138 — ATRIUM FLIXENE IFG VASCULAR GRAFT (August 17, 2012)
  • K121070 — C-QUR RPM MESH (April 26, 2012)
  • K113112 — CLEARWAY RX NB CATHETER (November 17, 2011)
  • K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT (October 5, 2010)
  • K093431 — CLEARWAY OTW MODEL 85912 (April 20, 2010)
  • K100076 — ATRIUM C-QUR OVT MESH (January 26, 2010)
  • K090909 — C-QUR V -PATCH MESH (June 4, 2009)
  • K082748 — ATRIUM PROLITE S MESH (January 14, 2009)
  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)

Other clearances for product code DXE

  • K240078 — Fogarty Thru-Lumen Embolectomy Catheter (August 28, 2024)
  • K241330 — Fogarty Fortis Arterial Embolectomy Catheter (July 2, 2024)
  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve (May 22, 2024)
  • K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (May 20, 2024)
  • K213771 — Merlin Aspiration System (January 27, 2022)
  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
  • K163353 — Needle's Eye Snare Retrieval Set - 54cm (July 11, 2017)

FDA data resources