Home / 510(k) Clearances / K973199

510(k) K973199

AMSINO SUCTION CATHETER by Amsino Intl., Inc. — Product Code BSY

K973199 is an FDA 510(k) premarket notification submitted by Amsino Intl., Inc. for the device "AMSINO SUCTION CATHETER". The FDA issued a decision of Substantially Equivalent on September 10, 1997. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Amsino Intl., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1997
Date Received
August 26, 1997
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 Amsino Intl., Inc.

  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE (January 12, 2000)
  • K974042 — AMSURE CLEANSING ENEMA SET (December 19, 1997)
  • K973107 — AMSINO I.V. ADMINISTRATION SET (October 2, 1997)
  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K950780 — AMSINO CERVICAL SCRAPER (July 25, 1995)
  • K951528 — AMSINO DISPOSABLE VIGINAL SPECULUM (May 11, 1995)

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)
  • 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