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510(k) K091841

BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 by Bridgepoint Medical — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2009
Date Received
June 22, 2009
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

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  • K111488 — MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 (June 30, 2011)
  • K101591 — STINGRAY ORIENTING BALLOON CATHETER (August 6, 2010)
  • K081130 — BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER (May 14, 2009)

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