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510(k) K000704

DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) by Dmc Medical, Ltd. — Product Code GBX

K000704 is an FDA 510(k) premarket notification submitted by Dmc Medical, Ltd. for the device "DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)". The FDA issued a decision of Substantially Equivalent on May 19, 2000. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Dmc Medical, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2000
Date Received
March 2, 2000
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 by Dmc Medical, Ltd.

  • K103736 — DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE (June 10, 2011)
  • K992932 — CIPA (ADULTS) CIPI (INFANTS) (June 7, 2000)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE (December 17, 2008)
  • K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (October 21, 2005)
  • K043515 — GRAFTSAVER (March 31, 2005)
  • K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P (January 10, 2002)
  • 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