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510(k) K873295

PROSTATIC URETHRO. BALLOON DILATATION CATHETER by Medi-Tech, Inc. — Product Code KOE

K873295 is an FDA 510(k) premarket notification submitted by Medi-Tech, Inc. for the device "PROSTATIC URETHRO. BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on July 31, 1989. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Medi-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1989
Date Received
August 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Urethral
Device Class
Class II
Regulation Number
876.5520
Review Panel
GU
Submission Type

Other clearances by Medi-Tech, Inc.

  • K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER (May 15, 1996)
  • K952345 — MEDI-TECH PLATFORM GUIDE CATHETER (August 17, 1995)
  • K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS (June 1, 1995)
  • K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (December 13, 1994)
  • K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (October 6, 1994)
  • K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLS (September 14, 1994)
  • K922990 — HEMODIALYSIS BATH (September 12, 1994)
  • K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (September 9, 1994)
  • K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL (October 22, 1990)
  • K895819 — MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (November 2, 1989)

Other clearances for product code KOE

  • K191061 — Optilume Basic Urological Balloon Dilation Catheter (January 2, 2020)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K962611 — BARD EAGLE INFLATION DEVICE (October 21, 1996)
  • K961904 — AQ HYDROPHILIC DILATORS (October 18, 1996)
  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K920551 — 120 FR OPTILUME PROSTATE BALLOON DILATOR (October 28, 1992)
  • K922349 — DOWD(TM) II (August 14, 1992)
  • K920711 — ENTRAC URETHRAL BALLOON DILATATION CATHETER (May 6, 1992)
  • K913477 — APEX(TM) PROSTATIC BALLOON DILATION CATHETER (December 27, 1991)

FDA data resources