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510(k) K944729

STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE by Coast Medical, Inc. — Product Code BSR

K944729 is an FDA 510(k) premarket notification submitted by Coast Medical, Inc. for the device "STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on December 21, 1994. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Coast Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1994
Date Received
September 26, 1994
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 Coast Medical, Inc.

  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)
  • K930929 — ESOPHAGEAL STETHOSCOPE (March 17, 1995)
  • K943270 — SURFACE TEMPERATURE PROBES (December 5, 1994)
  • K943495 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (September 8, 1994)
  • K943110 — GAS SAMPLING INTERFACES (August 19, 1994)
  • K930930 — COAST MEDICAL, INC. RECTAL PROBE (February 25, 1994)
  • K925781 — DISPOSABLE CUFFED ENDOTRACHEAL TUBE (April 19, 1993)
  • K925855 — DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE (February 18, 1993)
  • K921077 — DISPOSABLE INTUBATION KITS (August 25, 1992)
  • K921353 — NASOPHARYNGEAL AIRWAY (June 11, 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