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510(k) K874312

ACKRAD RETROGRADE URETHROGRAPHY SET by Ackrad Laboratories — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
October 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Ackrad Laboratories

  • K021272 — SIB CATHETER, MODEL 61-7005 (May 21, 2002)
  • K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TR (April 24, 2002)
  • K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 (April 16, 2002)
  • K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER (April 9, 1997)
  • K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 8, 1996)
  • K940176 — ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION (April 23, 1996)
  • K952542 — ACKRAD ESOPHAGEAL BALLOON CATHETER SET (April 23, 1996)
  • K953034 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) (August 29, 1995)
  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)

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