The following data is part of a premarket notification filed by Thoratec Laboratories Corp. with the FDA for Vascular Graft Tunneler-standard Curve, Mid Curve, Full Curve, Short Standard Curve, Vascular Graft Tunneler Accessories.
| Device ID | K001926 |
| 510k Number | K001926 |
| Device Name: | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-26 |
| Decision Date | 2000-09-22 |