NEXTSTITCH CARDIOVASCULAR VALVE SUTURE— 510(k) K001440

Name: FDA 510(k) clearance K001440
Creator: U.S. Food and Drug Administration
Published: 2000-11-13

Substantially Equivalent

Genzyme Surgical Product (Genzyme Biosurgery)

FDA 510(k) clearance K001440 for NEXTSTITCH CARDIOVASCULAR VALVE SUTURE, Substantially Equivalent on 2000-11-13. Applicant: Genzyme Surgical Product (Genzyme Biosurgery). Device class: 2.

Clearance details

Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
Product code: Code GAT
Device class: Class 2
Regulation: 21 CFR 878.5000
Advisory panel: General, Plastic Surgery
Date received: 2000-05-08
Decision date: 2000-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fall River, MA, US

Download summary PDF View on FDA.gov ↗

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K992088 — BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE1999-09-03
K991416 — ENDOSCOPIC CAMERA1999-07-20
K991191 — BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE1999-06-22
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Adverse events under product code GAT

product code GAT

Death: 19
Injury: 4,163
Malfunction: 8,646
Other: 2
Total: 12,830

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.