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510(k) K901310

ULTRASTAT NASAL CATHETER by Invotec International, Inc. — Product Code EMX

K901310 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "ULTRASTAT NASAL CATHETER". The FDA issued a decision of Substantially Equivalent on June 14, 1990. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Invotec International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1990
Date Received
March 20, 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 Invotec International, Inc.

  • K122040 — INVOTEC LARYNGEAL ELECTRODE (October 31, 2013)
  • K080740 — CLEARVIEW ENDOSCOPE COVER (December 31, 2008)
  • K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
  • K973580 — INVOTEC CLEAN PAD (December 10, 1997)
  • K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
  • K971000 — EPISTAXIS NASAL PACK (May 14, 1997)
  • K930114 — TRACHEOSTOMY T-TUBE (March 19, 1993)
  • K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (June 4, 1991)
  • K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)

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