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510(k) K042264

GUIDEWIRES by Rocket Medical Plc — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2004
Date Received
August 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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  • K000205 — EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES (April 19, 2000)
  • K000340 — HYSTALOG HSG CATHETER (April 19, 2000)

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