DeviceClearance

DUAL LUMEN EMBOLECTOMY CATHETER— 510(k) K970762

Substantially Equivalent

Applied Medical Resources

FDA 510(k) clearance K970762 for DUAL LUMEN EMBOLECTOMY CATHETER, Substantially Equivalent on 1997-03-28. Applicant: Applied Medical Resources. Device class: 2.

Clearance details

Applicant
Applied Medical Resources
Product code
Code DXE
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Launa Hills, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DXE

product code DXE
Death
27
Injury
258
Malfunction
2,266
Total
2,551

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K970762

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970762.

Data sourced from openFDA. This site is unofficial and independent of the FDA.