The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Vectra (tm) Vascular Access Graft-5mm Diameter,6mm Diameter And Vectra (tm) Vascular Access Graft For Revision-5mm Diame.
| Device ID | K001927 |
| 510k Number | K001927 |
| Device Name: | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | THORATEC LABORATORIES CORP. 6035 STONERIDGE DR. Pleasanton,, CA 94588 |
| Contact | Donald A Middlebrook |
| Correspondent | Donald A Middlebrook THORATEC LABORATORIES CORP. 6035 STONERIDGE DR. Pleasanton,, CA 94588 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-26 |
| Decision Date | 2000-12-18 |