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510(k) K081187

BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 by Bridgepoint Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2008
Date Received
April 28, 2008
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

Other clearances by Bridgepoint Medical

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  • K120881 — MANTARAY GUIDEWIRES (April 18, 2012)
  • K120129 — MANTARAY CATHETER (February 3, 2012)
  • K113589 — BIGBOSS CATHETER (January 4, 2012)
  • K111963 — BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER (August 10, 2011)
  • K111488 — MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 (June 30, 2011)
  • K101591 — STINGRAY ORIENTING BALLOON CATHETER (August 6, 2010)
  • K091841 — BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 (September 2, 2009)

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