VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME— 510(k) K001927
Substantially EquivalentThoratec Laboratories Corp.
FDA 510(k) clearance K001927 for VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME, Substantially Equivalent on 2000-12-18. Applicant: Thoratec Laboratories Corp.. Device class: 2.
Clearance details
- Applicant
- Thoratec Laboratories Corp.
- Product code
- Code DSY
- Device class
- Class 2
- Regulation
- 21 CFR 870.3450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code DSY
view allMore clearances from Thoratec Laboratories Corp.
view all- K001926 — VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES
- K851495 — THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY
- K833714 — RESPIRATORY ASSESSMENT SYSTEM
- K833265 — RESPIRATORY FLOW MODULE
- K831557 — INTRAOPERATIVE AUTOTRANSFUSION SYS
Adverse events under product code DSY
product code DSY- Death
- 29
- Injury
- 694
- Total
- 723
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.