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510(k) K935600

TRACHEAL SUCTION CATHETER by Puritas Health Care, Inc. — Product Code BSY

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 10, 1994
Date Received
November 19, 1993
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 Puritas Health Care, Inc.

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  • K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (May 5, 1994)
  • K940074 — Y-TYPE BLOOD ADMINISTRATION SET (April 21, 1994)
  • K940054 — MEASURED VOLUME SOLUTION ADMINISTRATION SET (April 15, 1994)
  • K940055 — MULTISET (April 15, 1994)
  • K935583 — SUCTION SET, TRACHAEL (April 11, 1994)
  • K940056 — WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM (April 4, 1994)
  • K940070 — STOPCOCK INTRAVENOUS THERAPY (April 4, 1994)
  • K935532 — TRANSFER SET (April 4, 1994)

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  • 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)