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510(k) K992796

ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 by Image-Guided Neurologics, Inc. — Product Code HCA

K992796 is an FDA 510(k) premarket notification submitted by Image-Guided Neurologics, Inc. for the device "ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000". The FDA issued a decision of Substantially Equivalent on October 25, 1999. The device falls under product code HCA (Catheter, Ventricular), a Class II device regulated under 21 CFR 882.4100. Image-Guided Neurologics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1999
Date Received
August 19, 1999
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 Image-Guided Neurologics, Inc.

  • K050772 — NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 (April 21, 2005)
  • K043091 — NAVIGUS NEXDRIVE, MODEL MI-3000 (February 7, 2005)
  • K040334 — NAVIGUS PASSIVE PROBE, MODEL NP-1000 (October 4, 2004)
  • K040834 — NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 (June 3, 2004)
  • K033619 — NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 (March 2, 2004)
  • K031885 — NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX (August 21, 2003)
  • K024201 — NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 (March 12, 2003)
  • K023949 — NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES (February 25, 2003)
  • K022100 — NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1 (September 25, 2002)
  • K012719 — NAVIGUS II MR (October 22, 2001)

Other clearances for product code HCA

  • K161731 — Cleveland Multiport Ventricular Catheter Set (March 27, 2017)
  • 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)
  • K003322 — CODMAN BACTISEAL CATHETERS (October 1, 2001)
  • K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (December 16, 1998)
  • K834477 — DISPOS. SCOTT CANNULAS 16-1054 ETC. (March 19, 1984)

FDA data resources