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Acumen Medical, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12

Categories0

Latest FDA decision

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

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