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Abbott Vascular

34 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Deliver recall (Z-0115-2023)Abbott Vascular2022-10-20
Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delive recall (Z-0116-2023)Abbott Vascular2022-10-20
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPA recall (Z-0117-2023)Abbott Vascular2022-10-20
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERIL recall (Z-1095-2022)Abbott Vascular2022-05-19
NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC Th recall (Z-1128-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC T recall (Z-1129-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC T recall (Z-1130-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC T recall (Z-1131-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC Th recall (Z-1132-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC Th recall (Z-1133-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC T recall (Z-1134-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC T recall (Z-1135-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC Th recall (Z-1136-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC T recall (Z-1137-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC Th recall (Z-1138-2020)Abbott Vascular2020-02-14
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC T recall (Z-1139-2020)Abbott Vascular2020-02-14
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM recall (Z-1140-2020)Abbott Vascular2020-02-14
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12M recall (Z-1141-2020)Abbott Vascular2020-02-14
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15M recall (Z-1142-2020)Abbott Vascular2020-02-14
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM recall (Z-1143-2020)Abbott Vascular2020-02-14
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12M recall (Z-1144-2020)Abbott Vascular2020-02-14
Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a tempo recall (Z-2151-2017)Abbott Vascular2017-06-01
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012 recall (Z-2037-2017)Abbott Vascular2017-05-12
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, recall (Z-2038-2017)Abbott Vascular2017-05-12
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449 recall (Z-2039-2017)Abbott Vascular2017-05-12
MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the recall (Z-0911-2016)Abbott Vascular2016-03-07
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers recall (Z-0757-2013)Abbott Vascular2013-01-31
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in recall (Z-2450-2012)Abbott Vascular2012-09-25
Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnosti recall (Z-2791-2011)Abbott Vascular2011-07-12
Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For us recall (Z-2792-2011)Abbott Vascular2011-07-12
Guidant RAPIDO Cut-Away Guiding Catheter, 6F. Part Numbers: 66676-201 and 667552-100. For recall (Z-2793-2011)Abbott Vascular2011-07-12
RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 Th recall (Z-0337-2011)Abbott Vascular2010-11-10
RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 T recall (Z-0338-2011)Abbott Vascular2010-11-10
RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061 recall (Z-0339-2011)Abbott Vascular2010-11-10

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Every clearance here is in the API, with alerts when new ones post.