FDA 510(k) Applications for Medical Device:
Console, Heart-Lung Machine, Cardiopulmonary Bypass
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K964017 | AVECOR CARDIOVASCULAR, INC. |
13010 COUNTRY RD. 6 | PLYMOUTH | MN | 55441 |
| K021694 | CARDIOVENTION, INC. |
3045 STENDER WAY | SANTA CLARA | CA | 95054 |
| K030141 | CARDIOVENTION, INC. |
3045 STENDER WAY | SANTA CLARA | CA | 95054 |
| K202125 | Century HLM, LLC |
3110 N. Oakland, STE 101 | Mesa | AZ | 85215 |
| K943803 | JANUS BIOMEDICAL, INC. |
2525 HARTFORD RD. | AUSTIN | TX | 78703 |
| K090006 | LIFEBRIDGE MEDIZINTECHNIK AG |
1282 ROUND HILL RD. | BRYN MAWR | PA | 19010 |
| K221373 | LivaNova Deutschland GmbH |
Lindberghstr. 25 | Munich | 80939 | |
| K232291 | LivaNova Deutschland GmbH |
Lindberghstr. 25 | Munich | 80939 | |
| K210130 | LivaNova Deutschland GmbH |
Lindberghstr. 25 | Munich | 80939 | |
| K133598 | MAQUET CARDIOPULMONARY AG |
45 BARBOUR POND DRIVE | WAYNE | NJ | 07470 |
| K102726 | MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 | HIRRLINGEN | 72145 | |
| K002116 | MEDICAL DEVICE CONSULTANTS, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760-4153 |
| K052555 | RAND S.R.L. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K070213 | RAND S.R.L. |
7611 NORTHLAND DRIVE | MINNEAPOLIS | MN | 55428 |
| K091007 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K062396 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K071318 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K092463 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K093882 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K103762 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K060053 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K080832 | SORIN GROUP DEUTSCHLAND GMBH |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K173834 | Spectrum Medical Ltd |
Harrier 4, Meteor Business Park, Cheltenham Road East | Gloucester | GL2 9QL | |
| K190282 | Spectrum Medical Ltd |
Harrier 4, Meteor Business Park, Cheltenham Road East | Gloucester | GL2 9QL | |
| K011088 | STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K020571 | STOCKERT INSTRUMENTE GMBH |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K982014 | STOECKERT INSTRUMENTE |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K002118 | STOECKERT INSTRUMENTE |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K950990 | STOECKERT INSTRUMENTE |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K131041 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103 |
| K022947 | TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. | ANN ARBOR | MI | 48103 |
| K151349 | Terumo Cardiovascular Systems Corporation |
6200 Jackson Road | Ann Arbor | MI | 48103 |
| K153376 | Terumo Cardiovascular Systems Corporation |
6200 Jackson Road | Ann Arbor | MI | 48103 |
| K163531 | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
6200 JACKSON ROAD | ANN ARBOR | MI | 48103 |
| K172220 | Terumo Cardiovascular Systems Corporation |
6200 Jackson Road | Ann Arbor | MI | 48103 |
| K221895 | Terumo Cardiovascular Systems Corporation |
6200 Jackson Road | Ann Arbor | MI | 48103 |
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