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510(k) K120154

INTRAUTERINE INSEMINATION (IUI) CATHETER by Catheter Research, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2012
Date Received
January 18, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

Other clearances by Catheter Research, Inc.

  • K123258 — THE ADVANCE CATHETER FOR HSG AND SIS (January 31, 2013)
  • K032835 — H/S CATHETER SET (December 11, 2003)
  • K020292 — UTERINE INJECTOR (April 17, 2002)
  • K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE (March 19, 1998)
  • K974357 — UTERINE MANIPULATOR/INJECTOR (February 2, 1998)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K946044 — DISPOSABLE GAS SAMPLING LINES (December 27, 1994)

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  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)