Home / 510(k) Clearances / K191947

510(k) K191947

VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord by Maquet Cardiovascular, LLC — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2019
Date Received
July 22, 2019
Clearance Type
Traditional
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).

Other clearances by Maquet Cardiovascular, LLC

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  • K191930 — 7 mm Extended Length Endoscope (April 15, 2020)
  • 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)
  • K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXX (September 10, 2012)
  • K101274 — VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM (June 11, 2010)

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