Acumen Medical, Inc. is one of 22290 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Acumen Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59, MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7, MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
12
Total
12
Cleared
0
Denied
Acumen Medical, Inc. has 12 FDA 510(k) cleared cardiovascular devices. Based in Mountain View, US.
Historical record: 12 cleared submissions from 2004 to 2009.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Acumen Medical, Inc.
12 devices
Cleared
Feb 17, 2009
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
Cardiovascular
55d
Cleared
Mar 13, 2008
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9,...
Cardiovascular
17d
Cleared
May 22, 2007
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45,...
Cardiovascular
99d
Cleared
Apr 06, 2007
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
Cardiovascular
92d
Cleared
Feb 23, 2007
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
Cardiovascular
32d
Cleared
Aug 23, 2006
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90,...
Cardiovascular
27d
Cleared
Aug 18, 2006
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67
Cardiovascular
28d
Cleared
Jun 19, 2006
ACUMEN SINGLE-LUMEN DELIVERY SHEATH
Cardiovascular
195d
Cleared
Sep 01, 2005
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
Cardiovascular
85d
Cleared
Feb 03, 2005
MODIFIED ACUMEN SHEATH, MODEL TTWO767
Cardiovascular
30d
Cleared
Dec 28, 2004
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
Cardiovascular
118d
Cleared
Oct 26, 2004
ACUMEN SHEATH, MODEL TTW7807
Cardiovascular
55d