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510(k) K960488

NEO 2 LINE SUCTION SYSTEM by Alcove Medical, Inc. — Product Code BSY

K960488 is an FDA 510(k) premarket notification submitted by Alcove Medical, Inc. for the device "NEO 2 LINE SUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 26, 1996. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1996
Date Received
February 1, 1996
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 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)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)
  • K955645 — CATH-GUIDE (March 12, 1996)

FDA data resources