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510(k) K062302

MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM by Millicore AB — Product Code KDQ

K062302 is an FDA 510(k) premarket notification submitted by Millicore AB for the device "MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 6, 2006. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2006
Date Received
August 8, 2006
Clearance Type
Traditional
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 for product code KDQ

  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K043582 — OCEAN CHEST DRAIN (January 21, 2005)
  • 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