PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)— 510(k) K945461

Substantially Equivalent

Medtronics Interventional Vascular

FDA 510(k) clearance K945461 for PITON(TM) Y-PACK AND PITON(TM) TRI-PACK), Substantially Equivalent on 1995-02-03. Applicant: Medtronics Interventional Vascular.

Clearance details

Applicant: Medtronics Interventional Vascular
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1994-11-07
Decision date: 1995-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.