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Acumen Medical, Inc.

12 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 (K083855)Acumen Medical, Inc.2009-02-17
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 (K080500)Acumen Medical, Inc.2008-03-13
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 (K070396)Acumen Medical, Inc.2007-05-22
ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM (K070051)Acumen Medical, Inc.2007-04-06
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY (K070197)Acumen Medical, Inc.2007-02-23
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 (K062145)Acumen Medical, Inc.2006-08-23
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 (K062084)Acumen Medical, Inc.2006-08-18
ACUMEN SINGLE-LUMEN DELIVERY SHEATH (K053400)Acumen Medical, Inc.2006-06-19
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 (K051515)Acumen Medical, Inc.2005-09-01
MODIFIED ACUMEN SHEATH, MODEL TTWO767 (K050015)Acumen Medical, Inc.2005-02-03
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 (K042381)Acumen Medical, Inc.2004-12-28
ACUMEN SHEATH, MODEL TTW7807 (K042376)Acumen Medical, Inc.2004-10-26

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Every clearance here is in the API, with alerts when new ones post.