Medical Device Manufacturer · US , Orinda , CA

Bridgepoint Medical - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2008

Recent clearances: STINGRAY GUIDEWIRES, MANTARAY GUIDEWIRES, BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES

View 14 510(k) Devices ↓
14
Total
14
Cleared
0
Denied

FDA 510(k) Regulatory Record - Bridgepoint Medical Cardiovascular ✕

14 devices
1-12 of 14
Cleared Nov 08, 2012
STINGRAY GUIDEWIRES
K122795 · DQX
Cardiovascular · 57d
Cleared Jul 13, 2012
MANTARAY GUIDEWIRES
K121745 · DQX
Cardiovascular · 29d
Cleared CT May 22, 2012
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
K120533 · PDU
Cardiovascular · 90d
Cleared Apr 18, 2012
MANTARAY GUIDEWIRES
K120881 · DQX
Cardiovascular · 26d
Cleared Feb 03, 2012
MANTARAY CATHETER
K120129 · DQY
Cardiovascular · 17d
Cleared Jan 04, 2012
BIGBOSS CATHETER
K113589 · DQY
Cardiovascular · 30d
Cleared Aug 10, 2011
BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
K111963 · DQY
Cardiovascular · 30d
Cleared Jun 30, 2011
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
K111488 · DQX
Cardiovascular · 30d
Cleared Aug 06, 2010
STINGRAY ORIENTING BALLOON CATHETER
K101591 · DQY
Cardiovascular · 60d
Cleared Sep 02, 2009
BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000
K091841 · DQY
Cardiovascular · 72d
Cleared May 14, 2009
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
K081130 · DQY
Cardiovascular · 388d
Cleared Feb 20, 2009
STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
K083727 · DQX
Cardiovascular · 67d
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