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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 Mar 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 14 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 12, 1985
Date Received
Dec 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
510(k) Exempt

Other clearances by Consolidated Medical Equipment, Inc.

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

Other clearances for product code KDQ

  • K081718 — EXPRESS CHEST DRAIN (Jul 25, 2008)
  • K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (Oct 6, 2006)
  • K043582 — OCEAN CHEST DRAIN (Jan 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… (Aug 28, 1996)
  • K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (Jul 26, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (Jul 22, 1996)
  • K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (Apr 13, 1995)
  • K941818 — PM9000 VAC TRAP (Dec 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (Jul 13, 1993)

FDA data resources

Source: FDA 510(k) database entry for K844942. Report a data issue: hello@regdatalab.com.