Atlas FDA

INTRAOPERATIVE AUTOTRANSFUSION SYS

FDA 510(k) clearance K831557 · decided 1983-08-24

Clearance details

K-number
K831557
Device name
INTRAOPERATIVE AUTOTRANSFUSION SYS
Applicant
Thoratec Laboratories Corp.
Decision
Substantially Equivalent
Date received
1983-05-16
Decision date
1983-08-24
Days to decision
100 days
Clearance type
Traditional
Product code
CAC
Device class
2
Regulation number
868.5830
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S062)Thoratec Laboratories Corp.2016-06-14
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S061)Thoratec Laboratories Corp.2016-01-21
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S060)Thoratec Laboratories Corp.2015-06-04
THORATEC VENTRICULAR ASSIST DEVICE (P870072/S059)Thoratec Laboratories Corp.2014-03-18
THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S058)Thoratec Laboratories Corp.2013-12-19
THORATEC VENTRICULAR ASSIST DEVICE(VAD) (P870072/S057)Thoratec Laboratories Corp.2013-12-18
THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S055)Thoratec Laboratories Corp.2013-12-10
THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S054)Thoratec Laboratories Corp.2013-10-11