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510(k) K885131

KIT PAK SUCTION CATHETER KIT by Kit Pak, Inc. — Product Code BSY

K885131 is an FDA 510(k) premarket notification submitted by Kit Pak, Inc. for the device "KIT PAK SUCTION CATHETER KIT". The FDA issued a decision of Substantially Equivalent on January 9, 1989. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Kit Pak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1989
Date Received
December 12, 1988
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 Kit Pak, Inc.

  • K942959 — KIT PAK WET SALINE DRESSING (February 14, 1995)
  • K941499 — KIT PAK DRESSING CHANGE TRAY (July 20, 1994)
  • K932310 — KIT PAK INCONTINENT SKIN CARE KIT (June 1, 1994)
  • K934080 — URINARY DRAINAGE BAG (May 18, 1994)
  • K931013 — FOLEY CATHETER TRAY (August 9, 1993)
  • K923905 — WOUND DRESSING KIT (July 2, 1993)
  • K924051 — KIT PAK I.V. START KIT (June 22, 1993)
  • K923906 — FOLEY INSERTION TRAY (June 22, 1993)
  • K922051 — KIT PAK'S FLUSHING KIT (June 17, 1993)
  • K925281 — KIT PAK URINARY CARE SUPPLIES (April 19, 1993)

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