DeviceClearance

SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301— 510(k) K101659

Substantially Equivalent

Vascular Solutions, Inc.

FDA 510(k) clearance K101659 for SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301, Substantially Equivalent on 2010-12-16. Applicant: Vascular Solutions, Inc.. Device class: 2.

Clearance details

Applicant
Vascular Solutions, Inc.
Product code
Code DQY
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

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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, 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 K101659

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 K101659.

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