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510(k) K972964

ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE by Atrion Medical Products, Inc. — Product Code KOE

K972964 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on October 10, 1997. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1997
Date Received
August 11, 1997
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 Atrion Medical Products, Inc.

  • K060643 — QL LOCKING SYRINGE (July 12, 2006)
  • K043249 — ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (May 25, 2005)
  • K041158 — ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (June 16, 2004)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K020333 — ATRION MEDICAL QL FLUID DISPENSING SYRINGE (April 25, 2002)
  • K973633 — ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (January 16, 1998)
  • K973872 — ATRION MEDICAL COATED LACRIMAL INTUBATION SET (January 8, 1998)
  • K971100 — ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR (May 23, 1997)

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

FDA data resources