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510(k) K003322

CODMAN BACTISEAL CATHETERS by Codman & Shurtleff, Inc. — Product Code HCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2001
Date Received
October 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular
Device Class
Class II
Regulation Number
882.4100
Review Panel
NE
Submission Type

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  • K162437 — Codman EDS3 CSF External Drainage System (October 28, 2016)

Other clearances for product code HCA

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  • K123605 — SMARTFLOW CATHETER (August 16, 2013)
  • K031123 — CODMAN BACTISEAL BARIUM STRIPED CATHETERS (May 14, 2003)
  • K021481 — BRESAGEN CATHETER, MODEL CS-3000 (August 6, 2002)
  • K020728 — MIETHKE SHUNT SYSTEM (April 5, 2002)
  • K013005 — ACT 11 MP VENTRICULAR CATHETER (March 8, 2002)
  • K992796 — ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (October 25, 1999)
  • K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (December 16, 1998)
  • K834477 — DISPOS. SCOTT CANNULAS 16-1054 ETC. (March 19, 1984)