Home / 510(k) Clearances / K091733

510(k) K091733

VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500 by Maquet Cardiovascular, LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2009
Date Received
June 11, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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  • K132743 — HARVESTING CANNULA (December 3, 2013)
  • K131778 — FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT (November 14, 2013)
  • K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXX (September 10, 2012)

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