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510(k) K972076

EPI-MAX EPISTAXIS CATHETER by Boston Medical Products, Inc. — Product Code EMX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1997
Date Received
June 3, 1997
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 Boston Medical Products, Inc.

  • K091135 — RUTTER SUPRA STOMAL STENTS (September 14, 2009)
  • K972317 — MONTGOMERY THYROPLASTY IMPLANT SYSTEM (September 18, 1997)
  • K972459 — RHINOCELL NASAL PACKINGS (August 4, 1997)
  • K972096 — BIVALVE NASAL SPLINT (July 15, 1997)
  • K972078 — POST-STOP EPISTAXIS CATHETER (July 10, 1997)
  • K972092 — NASAL AIRWAY SPLINT (July 8, 1997)
  • K972151 — DOYLE COMBO NASAL AIRWAY SPLINT (July 7, 1997)
  • K972082 — CUSTOM NASAL SPLINT (July 3, 1997)
  • K972060 — NASAL SEPTAL BUTTON (July 3, 1997)
  • K972077 — EPI-STOP EPISTAXIS CATHETER (June 26, 1997)

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)