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510(k) K993786

RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY by Rusch Intl. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2000
Date Received
November 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Rusch Intl.

  • K033023 — INTERMITTENT URETHRAL CATHETERS (December 23, 2003)
  • K030559 — RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (June 30, 2003)
  • K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (June 17, 2003)
  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (March 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (December 23, 2002)
  • K021540 — RUSCH EDGAR TUBE (August 1, 2002)
  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (July 23, 2002)
  • K020714 — RUSCH FLONEIL; FLOCATH INTROGEL (July 1, 2002)
  • K010798 — RUSCH CANTOR TUBE (February 26, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (February 26, 2002)

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  • K233341 — Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, (May 20, 2024)
  • K223130 — Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP ( (August 30, 2023)
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