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510(k) K950700

BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA by C.R. Bard, Inc. — Product Code ODD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1995
Date Received
February 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To identify stones, tumors, or narrowing in the biliary tree.

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  • K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 (March 19, 2007)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)
  • K010993 — ALIEN RX MICRO CANNULA, MODEL 4530 (April 30, 2001)
  • K973205 — WILSON-COOK STRICTURE MEASURING CATHETER (November 24, 1997)
  • K963051 — ERCP CANNULA (March 28, 1997)
  • K953967 — ENDOSCOPIC CATHETER (January 22, 1996)
  • K950729 — OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) (March 17, 1995)