Acumen Medical, Inc. - FDA 510(k) Cleared Devices

Cleared Feb 17, 2009

MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59

K083855 · DYB

Cardiovascular · 55d

Cleared Mar 13, 2008

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9,...

K080500 · DYB

Cardiovascular · 17d

Cleared May 22, 2007

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45,...

K070396 · DYB

Cardiovascular · 99d

Cleared Apr 06, 2007

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM

K070051 · DQY

Cardiovascular · 92d

Cleared Feb 23, 2007

ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY

K070197 · DYB

Cardiovascular · 32d

Cleared Aug 23, 2006

MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90,...

K062145 · DYB

Cardiovascular · 27d

Cleared Aug 18, 2006

7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67

K062084 · DQY

Cardiovascular · 28d

Cleared Jun 19, 2006

ACUMEN SINGLE-LUMEN DELIVERY SHEATH

K053400 · DYB

Cardiovascular · 195d

Cleared Sep 01, 2005

MODIFIED ACUMEN SHEATH, MODEL TTW 10-65

K051515 · DYB

Cardiovascular · 85d

Cleared Feb 03, 2005

MODIFIED ACUMEN SHEATH, MODEL TTWO767

K050015 · DYB

Cardiovascular · 30d

Cleared Dec 28, 2004

CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508

K042381 · DQY

Cardiovascular · 118d

Cleared Oct 26, 2004

ACUMEN SHEATH, MODEL TTW7807

K042376 · DYB

Cardiovascular · 55d