Bridgepoint Medical

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2074-2012Class IIBridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, PrescriptJune 26, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K122795STINGRAY GUIDEWIRESNovember 8, 2012
K121745MANTARAY GUIDEWIRESJuly 13, 2012
K120533BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRESMay 22, 2012
K120881MANTARAY GUIDEWIRESApril 18, 2012
K120129MANTARAY CATHETERFebruary 3, 2012
K113589BIGBOSS CATHETERJanuary 4, 2012
K111963BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETERAugust 10, 2011
K111488MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003June 30, 2011
K101591STINGRAY ORIENTING BALLOON CATHETERAugust 6, 2010
K091841BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000September 2, 2009
K081130BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETERMay 14, 2009
K083727STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012February 20, 2009
K080987BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIESFebruary 6, 2009
K081187BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001October 8, 2008