Home / 510(k) Clearances / K902814

510(k) K902814

SUCTION CATHETER, STERILE by Orion Life Systems, Inc. — Product Code BSY

K902814 is an FDA 510(k) premarket notification submitted by Orion Life Systems, Inc. for the device "SUCTION CATHETER, STERILE". The FDA issued a decision of Substantially Equivalent on August 17, 1990. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Orion Life Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1990
Date Received
June 28, 1990
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 Orion Life Systems, Inc.

  • K943835 — PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID (January 24, 1995)
  • K943836 — PRE-FILLED 10CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943828 — STERILE WATER FOR IRRIGATION (November 21, 1994)
  • K943831 — PRE-FILLED 30CC INFLATION SYRINGE W/STERILE WATER (November 21, 1994)
  • K943830 — PRE-FILLED SYRINGE W/STERILE 0.9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943829 — PRE-FILLED SYSRINGE W/STERILE WATER (November 21, 1994)
  • K943832 — STERILE .9% SODIUM CHLORIDE FOR IRRATION (November 21, 1994)
  • K943834 — STERILE .9% SODIUM CHLORIDE SOLUTION (November 21, 1994)
  • K943833 — STERILE WATER FOR IRRATION (November 1, 1994)
  • K923168 — DUAL PORT ENTERAL Y-ADAPTOR (June 17, 1994)

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