FDA 510(k) Applications for Medical Device:
Controller, Temperature, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K001520 | ALPHA OMEGA, INC. |
2525 HARTFORD RD. | AUSTIN | TX | 78703 |
| K102147 | CARDIOQUIP LLP |
3827 OLD COLLEGE RD | BRYAN | TX | 77801 |
| K122813 | CINCINNATI SUB-ZERO PRODUCTS, INC. |
12011 MOSTELLER RD. | CINCINNATI | OH | 45241 |
| K031544 | JOSTRA AB |
2828 N. CRESCENT RIDGE DR. | THE WOODLANDS | TX | 77381 |
| K220635 | LivaNova Deutschland GmbH |
Lindbergh Strasse 25 | Munchen | 80939 | |
| K191402 | LivaNova Deutschland GmbH |
Lindberghstrasse 25 | Munich | 80939 | |
| K130300 | MAQUET CARDIOPULMONARY AG |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K014016 | MINNTECH CORP. |
14605 28TH AVE. NORTH | MINNEAPOLIS | MN | 55447 |
| K003145 | ORIGEN BIOMEDICAL, INC. |
2525 HARTFORD RD. | AUSTIN | TX | 78703-2428 |
| K140012 | SORIN GROUP DEUTSCHLAND GMBH |
14401 W 65TH WAY | ARVADA | CO | 80004 |
| K052601 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K212657 | Spectrum Medical Ltd. |
Harrier 4, Meteor Business Park, Cheltenham Road East | Gloucester | GL29QL | |
| K071521 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103 |
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