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510(k) K013005

ACT 11 MP VENTRICULAR CATHETER by Innerspace, Inc. — Product Code HCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2002
Date Received
September 6, 2001
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

Other clearances by Innerspace, Inc.

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  • K083378 — SYNERGY (September 29, 2009)
  • K072379 — MPS OXIPORT AND MPS OXIPORT PLUS (April 29, 2008)
  • K041838 — MPS (OR MPS-T) (March 1, 2005)
  • K013705 — ACT III VENTRICULAR CATHETER (September 9, 2002)
  • K010422 — ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER (June 28, 2001)
  • K003905 — ACTI-ICP MONITORING SYSTEM (June 15, 2001)

Other clearances for product code HCA

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  • K021481 — BRESAGEN CATHETER, MODEL CS-3000 (August 6, 2002)
  • K020728 — MIETHKE SHUNT SYSTEM (April 5, 2002)
  • K003322 — CODMAN BACTISEAL CATHETERS (October 1, 2001)
  • 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)