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510(k) K052286

DEUTSCH ANTI-BLOCKAGE WOUND DRAIN by The Catheter Exchange, Inc. — Product Code GBX

K052286 is an FDA 510(k) premarket notification submitted by The Catheter Exchange, Inc. for the device "DEUTSCH ANTI-BLOCKAGE WOUND DRAIN". The FDA issued a decision of Substantially Equivalent on October 21, 2005. 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
October 21, 2005
Date Received
August 22, 2005
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

Other clearances for product code GBX

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  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • 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)
  • K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (June 26, 1996)

FDA data resources