SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS— 510(k) K944668

Substantially Equivalent

Medtronics Interventional Vascular

FDA 510(k) clearance K944668 for SHERPA SHERPA II AND ASCENT CORONARY GUIDING CATHETERS, Substantially Equivalent on 1995-03-03. Applicant: Medtronics Interventional Vascular.

Clearance details

Applicant: Medtronics Interventional Vascular
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1994-09-13
Decision date: 1995-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.