PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT— 510(k) K905067

Name: FDA 510(k) clearance K905067
Creator: U.S. Food and Drug Administration
Published: 1991-03-18

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K905067 for PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT, Substantially Equivalent on 1991-03-18. Applicant: Pioneering Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code DSY
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1990-11-09
Decision date: 1991-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft2024-03-28

More clearances from Pioneering Technologies, Inc.

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K922025 — ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF1992-09-22
K905175 — PTI ANNULOPLASTY RING(STERILE)1992-02-14
K905068 — PTI INTRA-ART (TM) PICK-UP WICKS1991-12-31
K910067 — PTI STERNAL CLOSURE WIRE SUTURE1991-05-06
K901682 — PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS1990-07-03

Adverse events under product code DSY

product code DSY

Death: 29
Injury: 694
Total: 723

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.