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510(k) K871825

MECONIUM SUCTION CATHETER by Concord Laboratories, Inc. — Product Code BSY

K871825 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "MECONIUM SUCTION CATHETER". The FDA issued a decision of Substantially Equivalent on June 29, 1987. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1987
Date Received
May 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Suction, Tracheobronchial
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type

Other clearances by Concord Laboratories, Inc.

  • K883840 — DRI-VENT ARTERIAL BLOOD SAMPLING KIT (May 16, 1989)
  • K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (January 6, 1987)
  • K862039 — CONCORD CARE TRAY (July 3, 1986)
  • K854601 — SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH (January 10, 1986)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K851134 — REGIONAL ANESTHESIA TRAYS (July 15, 1985)
  • K842095 — EPIDURAL TRAYS (July 3, 1984)
  • K841486 — ARTERIAL BLOOD SAMPLING KITS (May 23, 1984)
  • K840987 — VAPORIZED HEPARIN (April 5, 1984)
  • K840986 — PREFILLED PULSATOR SYRINGE (April 5, 1984)

Other clearances for product code BSY

  • K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM (November 25, 2003)
  • K992902 — AMBU HAND POWER SUCTION PUMP (October 25, 1999)
  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K981910 — SUCTION CATHETER (August 24, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
  • K973199 — AMSINO SUCTION CATHETER (September 10, 1997)
  • K961707 — TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (March 11, 1997)
  • K964369 — TRACH CARE SET WITH MICROBAN (February 11, 1997)
  • K960488 — NEO 2 LINE SUCTION SYSTEM (April 26, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)

FDA data resources