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510(k) K942335

ACI SILICATH THORACIC CATHETER by American Catheter — Product Code GBX

K942335 is an FDA 510(k) premarket notification submitted by American Catheter for the device "ACI SILICATH THORACIC CATHETER". The FDA issued a decision of Substantially Equivalent on August 9, 1994. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1994
Date Received
May 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Irrigation
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

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  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (May 19, 2000)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K973703 — JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (December 4, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)

FDA data resources