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510(k) K043582

OCEAN CHEST DRAIN by Atrium Medical Corp. — Product Code KDQ

K043582 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "OCEAN CHEST DRAIN". The FDA issued a decision of Substantially Equivalent on January 21, 2005. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2005
Date Received
December 28, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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 KDQ

  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (October 6, 2006)
  • K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (May 5, 1999)
  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (July 26, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (July 22, 1996)
  • K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (April 13, 1995)
  • K941818 — PM9000 VAC TRAP (December 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)
  • K912704 — ATRIUM 2000 CHEST DRAIN (August 26, 1991)

FDA data resources