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510(k) K953226

PULM O2 SUCTION CATHETER TRAYS by Premium Plastics, Inc. — Product Code BSY

K953226 is an FDA 510(k) premarket notification submitted by Premium Plastics, Inc. for the device "PULM O2 SUCTION CATHETER TRAYS". The FDA issued a decision of Substantially Equivalent on August 8, 1995. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Premium Plastics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1995
Date Received
July 6, 1995
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 Premium Plastics, Inc.

  • K950851 — GENT-L-KARE TRACHEOSTOMY TRAYS (June 21, 1995)
  • K950850 — GENT-L-KARE LACERATION TRAYS (March 14, 1995)
  • K943740 — ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) (December 14, 1994)
  • K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT (October 24, 1989)
  • K893135 — GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER (June 22, 1989)
  • K850285 — GENT-L-KARE STERILE URETHRAL CATHETERIZATION TRAY (February 28, 1985)
  • K800440 — STERILE SPONGE BOWLS (April 29, 1980)
  • K771448 — STERILE SUTURE REMOVAL KIT (September 6, 1977)

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