Home / 510(k) Clearances / K972258

510(k) K972258

HI-CARE CLOSED SUCTION SYSTEM by Mallinckrodt Medical — Product Code BSY

K972258 is an FDA 510(k) premarket notification submitted by Mallinckrodt Medical for the device "HI-CARE CLOSED SUCTION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 29, 1997. The device falls under product code BSY (Catheters, Suction, Tracheobronchial), a Class I device regulated under 21 CFR 868.6810. Mallinckrodt Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1997
Date Received
June 17, 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 Mallinckrodt Medical

  • K082520 — SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES (October 2, 2008)
  • K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA (June 16, 2005)
  • K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EX (September 25, 1997)
  • K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF A (June 26, 1997)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K965132 — HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (March 20, 1997)
  • K962045 — ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT (November 26, 1996)
  • K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES (October 4, 1996)
  • K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED (March 13, 1996)
  • K954749 — MALLINCKRODT SHILEY 15MM CAP (January 24, 1996)

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)
  • 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