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510(k) K052274

GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 by Guidant Corporation — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2005
Date Received
August 22, 2005
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).

Other clearances by Guidant Corporation

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  • K053459 — OMNILINK .035 BILIARY STENT SYSTEM (April 12, 2006)
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  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
  • K052166 — MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 18, 2005)
  • K052165 — RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 16, 2005)
  • K041981 — GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSO (August 20, 2004)
  • K041762 — FINISHING WIRE SUPPORTRAK (August 6, 2004)
  • K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)

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