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510(k) K981910

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

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)

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  • K982945 — DUAL PURPOSE CLOSED CATHETER (September 22, 1998)
  • K972258 — HI-CARE CLOSED SUCTION SYSTEM (December 29, 1997)
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  • 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)