MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS— 510(k) K940063

Substantially Equivalent

Medtronics Interventional Vascular

FDA 510(k) clearance K940063 for MEDTRONIC INTERVENTIONAL VASCULAR Y-ADAPTER, TRI-ADAPTER, TRI-ADAPTER & ACCESSORY PACKS, Substantially Equivalent on 1994-03-29. Applicant: Medtronics Interventional Vascular.

Clearance details

Applicant: Medtronics Interventional Vascular
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1994-01-06
Decision date: 1994-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.