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510(k) K031459

RAPIDO CUT-AWAY CUTTER by Guidant Corp. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2003
Date Received
May 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K031398 — IS-1 HEMOSTASIS VALVE, MODEL 6799 (May 20, 2003)
  • K030512 — GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (May 14, 2003)
  • K030019 — MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE (January 24, 2003)

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