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510(k) K920468

AUGUSTINE STYLET by Augustine Medical, Inc. — Product Code BSR

K920468 is an FDA 510(k) premarket notification submitted by Augustine Medical, Inc. for the device "AUGUSTINE STYLET". The FDA issued a decision of Substantially Equivalent on April 23, 1992. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Augustine Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1992
Date Received
January 27, 1992
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 Augustine Medical, Inc.

  • K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (July 9, 2002)
  • K020077 — MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (January 31, 2002)
  • K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MO (September 6, 2000)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)
  • K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET (June 26, 1997)
  • K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (March 28, 1997)
  • K963672 — MODEL 90022 ROLLING STAND (January 6, 1997)
  • K960167 — SYSTEM, THERMAL REGULATING 74-DWJ (June 17, 1996)
  • K954446 — AUGUSTINE INTUBATION GUIDE (December 29, 1995)
  • K952864 — BAIR HUGGER MODEL 655 BLANKET (September 12, 1995)

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