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510(k) K953963

RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION by Rusch, Inc. — Product Code BTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1995
Date Received
August 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Bronchial (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5720
Review Panel
AN
Submission Type

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  • K963779 — RUSCH ENTERAL FEEDING TUBE (May 23, 1997)
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  • K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (December 17, 1996)
  • K955564 — RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE (June 28, 1996)
  • K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (June 27, 1996)

Other clearances for product code BTS

  • K951091 — RUSCH ENDOBRONCHIAL TUBE SETS (June 8, 1995)
  • K902116 — MODIFIED ENDOBRONCHIAL TUBE (August 3, 1990)
  • K834565 — ENDOBRONCHIAL TWIN LUMEN TUBE (January 17, 1984)
  • K833297 — BRONCHOSCOPY TUBE W/ULTRA LOCUFF (December 27, 1983)
  • K771219 — BRONCHO-CATH (August 4, 1977)