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510(k) K905133

STYLET TRACHAEL TUBE by Medical Devices, Inc. — Product Code BSR

K905133 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "STYLET TRACHAEL TUBE". The FDA issued a decision of Substantially Equivalent on April 22, 1991. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1991
Date Received
November 15, 1990
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

Other clearances by Medical Devices, Inc.

  • K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (February 5, 2001)
  • K930084 — MICRO-ARTHROSCOPE (September 1, 1995)
  • K940012 — SMARTBRACE ELECTRODE (December 5, 1994)
  • K943126 — ELECTROFLEX (December 5, 1994)
  • K935132 — HOME MICROCURRENT HMC (March 14, 1994)
  • K934619 — FLEXMATE (February 23, 1994)
  • K924897 — XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 (July 6, 1993)
  • K930053 — VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 (May 17, 1993)
  • K923914 — IF-II (TM), MODEL 7200 (November 6, 1992)
  • K920071 — MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 (July 21, 1992)

Other clearances for product code BSR

  • K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exc (August 11, 2017)
  • 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)
  • K952100 — RUSCH ENDOTRACHEAL TUBE STYLET (August 8, 1995)
  • K952266 — SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (June 12, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K950380 — FLEXTITIP STYLETTE (February 10, 1995)

FDA data resources