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510(k) K121745

MANTARAY GUIDEWIRES by Bridgepoint Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2012
Date Received
June 14, 2012
Clearance Type
Special
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

  • K122795 — STINGRAY GUIDEWIRES (November 8, 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)
  • 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)
  • K081130 — BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER (May 14, 2009)

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