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510(k) K950380

FLEXTITIP STYLETTE by Polamedco, Inc. — Product Code BSR

K950380 is an FDA 510(k) premarket notification submitted by Polamedco, Inc. for the device "FLEXTITIP STYLETTE". The FDA issued a decision of Substantially Equivalent on February 10, 1995. The device falls under product code BSR (Stylet, Tracheal Tube), a Class I device regulated under 21 CFR 868.5790. Polamedco, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
January 31, 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

Other clearances by Polamedco, Inc.

  • K983000 — CRICOTHYROTOMY TUBE (October 27, 1999)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K953793 — INTROSCOPE (November 29, 1995)
  • K950713 — AIRGUIDE STYLETTE (May 17, 1995)
  • K933596 — GASTRIC, CATHETER, IRRIGATION & ASPIRATION (February 13, 1995)
  • K920900 — POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES (March 18, 1992)
  • K900456 — POLAMEDCO NASOPAHARYNGEAL AIRWAY (April 19, 1990)
  • K900457 — CUFFED LINDER NASOTRACHEAL AIRWAY (April 16, 1990)
  • K894516 — VISOSHIELD(TM), SURGICAL EYE PROTECTOR (September 12, 1989)
  • K881496 — LINDER NASOTRACHEAL AIRWAY (May 31, 1988)

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)
  • K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (December 21, 1994)

FDA data resources