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510(k) K082725

GRAFTGUARD PRESSURE CONTROLLING SYRINGE by Maquet Cardiovascular, LLC — Product Code GBX

K082725 is an FDA 510(k) premarket notification submitted by Maquet Cardiovascular, LLC for the device "GRAFTGUARD PRESSURE CONTROLLING SYRINGE". The FDA issued a decision of Substantially Equivalent on December 17, 2008. The device falls under product code GBX (Catheter, Irrigation), a Class I device regulated under 21 CFR 878.4200. Maquet Cardiovascular, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2008
Date Received
September 17, 2008
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 Maquet Cardiovascular, LLC

  • K252445 — Fusion Bioline Vascular Graft (April 27, 2026)
  • K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemop (May 30, 2025)
  • K243918 — Vasoview Hemopro 3 Power Supply (February 26, 2025)
  • K233879 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemop (February 27, 2024)
  • K191930 — 7 mm Extended Length Endoscope (April 15, 2020)
  • K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Ex (September 17, 2019)
  • K153194 — VASOVIEW HemoPro Endoscopic Vessel Harvesting System (April 19, 2016)
  • K153523 — FUSION Vascular Graft (February 16, 2016)
  • K132743 — HARVESTING CANNULA (December 3, 2013)
  • K131778 — FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT (November 14, 2013)

Other clearances for product code GBX

  • K131659 — MOERAE VEIN PREPARATION KIT (March 3, 2014)
  • 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)
  • K961295 — SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (June 26, 1996)

FDA data resources