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510(k) K952100

RUSCH ENDOTRACHEAL TUBE STYLET by Rusch, Inc. — Product Code BSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1995
Date Received
May 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Tracheal Tube
Device Class
Class I
Regulation Number
868.5790
Review Panel
AN
Submission Type

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  • K993194 — RUSCH MANUAL RESUSCITATOR BAG (March 24, 2000)
  • K980870 — RUSCH SILICONE FOLEY CATHETER (June 9, 1998)
  • K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETER (January 27, 1998)
  • K963779 — RUSCH ENTERAL FEEDING TUBE (May 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • 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 BSR

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  • K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)
  • K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRA (May 9, 1996)
  • K943104 — MOLLOY INTUBATING STYLETTE (April 18, 1996)
  • K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (February 6, 1996)
  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K952266 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (June 12, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)