Atlas FDA

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES

FDA 510(k) clearance K001926 · decided 2000-09-22

Clearance details

K-number
K001926
Device name
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
Applicant
Thoratec Laboratories Corp.
Decision
Substantially Equivalent
Date received
2000-06-26
Decision date
2000-09-22
Days to decision
88 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Pleasanton, CA, 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