FDA 510(k) Applications Submitted by KEN COLLINS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K014241 |
12/26/2001 |
COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D |
ALSIUS CORP. |
| K070161 |
01/17/2007 |
QUATTRO CATHETER MODEL IC4593 |
ALSIUS CORP. |
| K060308 |
02/07/2006 |
COOLGARD 3000 |
ALSIUS CORP. |
| K030421 |
02/10/2003 |
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM |
ALSIUS CORP. |
| K091121 |
04/17/2009 |
ORTHOSTAT |
ORTHOCON, INC. |
| K051912 |
07/14/2005 |
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B |
ALSIUS CORP. |
| K072234 |
08/10/2007 |
THERMOGARD XP THERMAL REGULATION SYSTEM |
ALSIUS CORP. |
| K052443 |
09/06/2005 |
ICY CATHETER, MODEL IC-3893A |
ALSIUS CORP. |
| K193256 |
11/26/2019 |
Anjon Bremer Halo System |
Anjon Holdings LLC |
| K063829 |
12/26/2006 |
THERMOGARD THERMAL REGULATION SYSTEM |
ALSIUS CORP. |
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