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510(k) K081130

BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER by Bridgepoint Medical — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2009
Date Received
April 21, 2008
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

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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