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510(k) K111963

BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER by Bridgepoint Medical — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2011
Date Received
July 11, 2011
Clearance Type
Special
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

  • K122795 — STINGRAY GUIDEWIRES (November 8, 2012)
  • K121745 — MANTARAY GUIDEWIRES (July 13, 2012)
  • K120533 — BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES (May 22, 2012)
  • K120881 — MANTARAY GUIDEWIRES (April 18, 2012)
  • K120129 — MANTARAY CATHETER (February 3, 2012)
  • K113589 — BIGBOSS CATHETER (January 4, 2012)
  • 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)
  • K081130 — BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER (May 14, 2009)

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