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87 devices found
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Manufacturer: Cardiacassist, Inc.
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Device · Manufacturer · Authorizations
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Tandemheart Pump
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K110493
Active
Cleared 20 Sep 2011
Active
510(k)
510(k)
II
Tandemheart Transseptal Cannula- Ef 72
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K082425
Active
Cleared 18 Sep 2008
Active
510(k)
510(k)
II
Tandemheart Transseptal Cannula Set-Ef, Model 5140-6221
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K052570
Active
Cleared 17 Jan 2006
Active
510(k)
510(k)
II
Protek Solo 24 Fr Venous Cannula Set
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K162214
Active
Cleared 30 Nov 2016
Active
510(k)
510(k)
II
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K162181
Active
Cleared 6 Jan 2017
Active
510(k)
510(k)
II
TandemHeart Pump and Escort Controller
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K202751
Active
Cleared 26 Mar 2021
Active
510(k)
510(k)
II
LifeSPARC System
Cardiacassist, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
FDA 510(k)
K233736
Active
Cleared 19 Jan 2024
Active
510(k)
510(k)
II
3 variants
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