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510(k) K913477

APEX(TM) PROSTATIC BALLOON DILATION CATHETER by Peripheral Systems Group — Product Code KOE

K913477 is an FDA 510(k) premarket notification submitted by Peripheral Systems Group for the device "APEX(TM) PROSTATIC BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on December 27, 1991. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Peripheral Systems Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1991
Date Received
August 5, 1991
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 Peripheral Systems Group

  • K940804 — SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION (June 10, 1994)
  • K934433 — VANTAGE DIALTAION CATHETER (December 9, 1993)
  • K932777 — SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER (October 7, 1993)
  • K931327 — PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE (July 14, 1993)
  • K915554 — HI-TORQUE SPORT-T(TM) GUIDE WIRE (February 9, 1993)
  • K914979 — EDM(R) INFUSION CATHETER (September 16, 1992)
  • K913941 — PSG(TM) 20 GUAGE DOPPLER NEEDLE (February 27, 1992)
  • K915168 — PROFLEX 5 (February 19, 1992)
  • K913746 — SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM (December 17, 1991)
  • K904984 — ADVANCE 418(TM) (April 12, 1991)

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)
  • K902585 — UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (August 27, 1990)

FDA data resources