FDA 510(k) Applications Submitted by Bruce Backlund
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K150567 |
03/06/2015 |
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT |
Medtronic, Inc. |
| K090659 |
03/12/2009 |
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY |
MEDTRONIC INC. |
| K221074 |
04/12/2022 |
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device |
Stryker Corporation |
| K021229 |
04/18/2002 |
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 |
BECKMAN COULTER, INC. |
| K051040 |
04/25/2005 |
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
MEDTRONIC PERFUSION SYSTEMS |
| K201398 |
05/28/2020 |
SINUSPRIME Dilation System |
Stryker ENT |
| K101885 |
07/06/2010 |
MEDTRONIC C315 DELIVERY CATHETER |
MEDTRONIC INC. |
| K041830 |
07/07/2004 |
MAGELLAN RATIO DISPENSER KIT |
MEDTRONIC PERFUSION SYSTEMS |
| K052524 |
09/14/2005 |
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT |
MEDTRONIC PERFUSION SYSTEMS |
| K142673 |
09/19/2014 |
Bio-Medicus Adult Cannulae and Introducer |
Medtronic, Inc |
| K223294 |
10/26/2022 |
SpineJack« Expansion Kit |
Stryker Instruments |
| K143083 |
10/27/2014 |
Bio-Medicus Pediatric Cannula and Introducers |
MEDTRONIC, INC |
| K043080 |
11/08/2004 |
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR |
MEDTRONIC VASCULAR |
| K193118 |
11/12/2019 |
TGS Guidewire and updated Scopis Software |
Stryker ENT |
| K163172 |
11/14/2016 |
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit |
SMITHS MEDICAL ASD, INC. |
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