FDA 510(k) Applications Submitted by ACUMEN MEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K080500 |
02/25/2008 |
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 |
ACUMEN MEDICAL, INC. |
| K083855 |
12/24/2008 |
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 |
ACUMEN MEDICAL, INC. |
| K050015 |
01/04/2005 |
MODIFIED ACUMEN SHEATH, MODEL TTWO767 |
ACUMEN MEDICAL, INC. |
| K070051 |
01/04/2007 |
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM |
ACUMEN MEDICAL, INC. |
| K070197 |
01/22/2007 |
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY |
ACUMEN MEDICAL, INC. |
| K070396 |
02/12/2007 |
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 |
ACUMEN MEDICAL, INC. |
| K051515 |
06/08/2005 |
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 |
ACUMEN MEDICAL, INC. |
| K062084 |
07/21/2006 |
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 |
ACUMEN MEDICAL, INC. |
| K062145 |
07/27/2006 |
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 |
ACUMEN MEDICAL, INC. |
| K042376 |
09/01/2004 |
ACUMEN SHEATH, MODEL TTW7807 |
ACUMEN MEDICAL, INC. |
| K042381 |
09/01/2004 |
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 |
ACUMEN MEDICAL, INC. |
| K053400 |
12/06/2005 |
ACUMEN SINGLE-LUMEN DELIVERY SHEATH |
ACUMEN MEDICAL, INC. |
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