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510(k) K810574

SUCTION COLLECTION BOTTLE, DISPOSABLE by Harvard Laboratories — Product Code KDQ

K810574 is an FDA 510(k) premarket notification submitted by Harvard Laboratories for the device "SUCTION COLLECTION BOTTLE, DISPOSABLE". The FDA issued a decision of Substantially Equivalent on April 21, 1981. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Harvard Laboratories has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1981
Date Received
March 3, 1981
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 Harvard Laboratories

  • K822765 — SIGMOIDOSCOPE, FLEXIBLE (November 17, 1982)
  • K810573 — TUBE FEEDING SET (April 23, 1981)
  • K800878 — SECONDARY I.V. TUBING SETS (June 17, 1980)
  • K800879 — CLEAR PLASTIC CONNECTING TUBES (June 17, 1980)
  • K800877 — ANESTHESIA EXTENSION TUBES (June 17, 1980)
  • K800880 — PLASTIC TUBING ADAPTERS 5-IN-1- (May 14, 1980)
  • K800881 — DISPOSABLE BERMAN AIRWAYS (May 8, 1980)

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