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510(k) K033333

SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B by Aomori Olympus Co., Ltd. — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
October 16, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Aomori Olympus Co., Ltd.

  • K042160 — SONOSURG TROCAR (January 25, 2005)
  • K041566 — SONOSURG ULTRASONIC SURGICAL SYSTEM (September 8, 2004)
  • K031523 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (October 1, 2003)
  • K031710 — OLYMPUS ULTRASONIC SURGICAL SYSTEM (August 29, 2003)
  • K021672 — PANCREATIC DRAINAGE TUBE (April 16, 2003)
  • K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C (March 28, 2003)

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  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
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