FDA 510(k) Applications Submitted by Brian Schmidt
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K140523 |
03/04/2014 |
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM |
COLOPLAST A/S |
| K100878 |
03/30/2010 |
SELF CATH CATHETER |
COLOPLAST MANUFACTURING US, LLC |
| K131072 |
04/17/2013 |
ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC |
COLOPLAST A/S |
| K121457 |
05/16/2012 |
SPEEDICATH COMPACT SET (12 FR) |
COLOPLAST CORP. |
| K121458 |
05/16/2012 |
SPEEDICATH COMPACT SET (12/18 FR) |
COLOPLAST A/S |
| K102485 |
08/30/2010 |
RE-TRACE URETERAL ACCESS SHEATH |
COLOPLAST A/S |
| K112860 |
09/30/2011 |
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER |
COLOPLAST A/S |
| K103254 |
11/03/2010 |
PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE |
COLOPLAST A/S |
| K143182 |
11/05/2014 |
Speedicath Compact Male |
COLOPLAST A/S |
| K123675 |
11/30/2012 |
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR |
COLOPLAST A/S |
|
|
