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510(k) K861949

SUCTION CATHETER KIT by Medi-Craft , Ltd. — Product Code BSY

K861949 is an FDA 510(k) premarket notification submitted by Medi-Craft , Ltd. for the device "SUCTION CATHETER KIT". The FDA issued a decision of Substantially Equivalent on October 22, 1986. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Medi-Craft , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1986
Date Received
May 20, 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 Medi-Craft , Ltd.

  • K800508 — STOMACH TUBES (April 8, 1980)
  • K800510 — RECTAL & HARRIS FLUSH TUBES (April 8, 1980)
  • K800507 — FEEDING TUBES (April 8, 1980)
  • K800505 — URETHRAL CATHETER (April 8, 1980)
  • K800509 — CONNECTING TUBES (March 25, 1980)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K800503 — SUCTION CATHETER (March 18, 1980)
  • K800504 — OXYGEN CONNECTING TUBES (March 18, 1980)

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