FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX— 510(k) K964663

Substantially Equivalent

Rmds, Inc.

FDA 510(k) clearance K964663 for FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX, Substantially Equivalent on 1997-12-11. Applicant: Rmds, Inc..

Clearance details

Applicant: Rmds, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1996-11-21
Decision date: 1997-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.