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510(k) K981910

SUCTION CATHETER by Ni-Med, Inc. — Product Code BSY

K981910 is an FDA 510(k) premarket notification submitted by Ni-Med, Inc. for the device "SUCTION CATHETER". The FDA issued a decision of Substantially Equivalent on August 24, 1998. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Ni-Med, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1998
Date Received
June 1, 1998
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 Ni-Med, Inc.

  • K875315 — I.V. START KITS (February 17, 1988)
  • K872824 — P. URINE METER, 250CC (October 14, 1987)

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)
  • 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)
  • K955645 — CATH-GUIDE (March 12, 1996)

FDA data resources