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510(k) K863497

SUCTION CATHETER KIT by Welmed Systems, Inc. — Product Code BSY

K863497 is an FDA 510(k) premarket notification submitted by Welmed Systems, Inc. for the device "SUCTION CATHETER KIT". The FDA issued a decision of Substantially Equivalent on October 6, 1986. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Welmed Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1986
Date Received
September 9, 1986
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 Welmed Systems, Inc.

  • K863282 — CARE + PLUS CATHETER CARE TRAY (October 31, 1986)
  • K863281 — CARE + PLUS IRREGATION TRAY (October 31, 1986)
  • K863284 — I.V. START KIT (September 22, 1986)
  • K863283 — CARE + PLUS SUTURE REMOVAL TRAY (September 15, 1986)
  • K862663 — TRACHEOSTOMY CARE TRAY (July 30, 1986)
  • K862219 — T.P.N. DRESSING CHANGE TRAY (July 8, 1986)

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