FDA 510(k) Applications Submitted by DONALD FICKETT
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K060155 |
01/20/2006 |
15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS |
SPIRE BIOMEDICAL, INC. |
K040509 |
02/27/2004 |
ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40 |
SPIRE BIOMEDICAL INC |
K021212 |
04/17/2002 |
24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS |
SPIRE BIOMEDICAL INC |
K041559 |
06/10/2004 |
55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 |
SPIRE BIOMEDICAL INC |
K022000 |
06/19/2002 |
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES) |
SPIRE BIOMEDICAL INC |
K032061 |
07/03/2003 |
DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH |
SPIRE BIOMEDICAL, INC. |
K022620 |
08/07/2002 |
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT |
SPIRE BIOMEDICAL, INC. |
K022644 |
08/08/2002 |
RETRO REPAIR KIT, MODEL PRRK5 |
SPIRE BIOMEDICAL, INC. |
K013160 |
09/21/2001 |
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER |
SPIRE BIOMEDICAL INC |
K042858 |
10/15/2004 |
55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS |
SPIRE BIOMEDICAL, INC. |
K090811 |
03/25/2009 |
INSPIRA HD, MODEL: NL1000 |
NEUROLOGICA CORPORATION |
K102677 |
09/15/2010 |
BODYTOM NL 4000 |
NEUROLOGICA CORPORATION |
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