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510(k) K844942

PLURA-GARD CHEST DRAINAGE SYSTEM by Consolidated Medical Equipment, Inc. — Product Code KDQ

K844942 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "PLURA-GARD CHEST DRAINAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Consolidated Medical Equipment, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
December 20, 1984
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 by Consolidated Medical Equipment, Inc.

  • K854040 — I.V. DRESSING (January 9, 1986)
  • K850130 — PRN ECG ELECTRODE (April 9, 1985)
  • K850132 — DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (April 9, 1985)
  • K850037 — CLOSED WOUND DRAIN (March 19, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (March 5, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (March 5, 1985)
  • K850133 — VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (February 28, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (February 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (February 21, 1985)
  • K844371 — HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE (February 20, 1985)

Other clearances for product code KDQ

  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (October 6, 2006)
  • 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)

FDA data resources