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510(k) K900583

MODIFIED BIVONA EPISTAXIS CATHETER by Bivona Medical Technologies — Product Code EMX

K900583 is an FDA 510(k) premarket notification submitted by Bivona Medical Technologies for the device "MODIFIED BIVONA EPISTAXIS CATHETER". The FDA issued a decision of Substantially Equivalent on August 9, 1990. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Bivona Medical Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1990
Date Received
February 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
Submission Type

Other clearances by Bivona Medical Technologies

  • K952700 — SUPERSLICK (October 31, 1995)
  • K942025 — BURGET NASAL STENT (October 27, 1995)
  • K944178 — BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES (October 27, 1994)
  • K935053 — BIVONA NASAL TURBINATE STENT (July 1, 1994)
  • K933398 — BIVONA ILLUMINATED ENDOTRACHEAL TUBE (October 6, 1993)
  • K931749 — BIVONA(R) ICU ENDOTRACHEAL TUBE (August 10, 1993)
  • K922665 — BIVONA HYPERFLEX TRACHEOSTOMY TUBE (January 7, 1993)
  • K923878 — BIVONA CUSTOMIZED TRACHEOSTOMY TUBES (December 29, 1992)
  • K920604 — BIVONA TRACHEAL T-TUBE STENT (July 27, 1992)
  • K915761 — BIVONA-COLORADO VOICE PROSTHESIS (June 29, 1992)

Other clearances for product code EMX

  • K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (November 14, 2022)
  • K041446 — NASALCEASE (July 1, 2004)
  • K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR- (May 23, 2000)
  • K993362 — HYLASINE (March 13, 2000)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K982731 — MEROGEL NASAL DRESSING AND SINUS STENT (February 2, 1999)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K981966 — NOSEBLEED NOSECLIP (August 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)

FDA data resources