PTI ANNULOPLASTY RING(STERILE)— 510(k) K905175

Name: FDA 510(k) clearance K905175
Creator: U.S. Food and Drug Administration
Published: 1992-02-14

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K905175 for PTI ANNULOPLASTY RING(STERILE), Substantially Equivalent on 1992-02-14. Applicant: Pioneering Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code KRH
Device class: Class 2
Regulation: 21 CFR 870.3800
Advisory panel: Cardiovascular
Date received: 1990-11-19
Decision date: 1992-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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K910067 — PTI STERNAL CLOSURE WIRE SUTURE1991-05-06
K905067 — PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT1991-03-18
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Adverse events under product code KRH

product code KRH

Death: 45
Injury: 2,235
Total: 2,280

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.