DeviceClearance

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035— 510(k) K123632

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K123632 for 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035, Substantially Equivalent on 2013-01-25. Applicant: Spectranetics Corp.. Device class: 2.

Clearance details

Applicant
Spectranetics Corp.
Product code
Code MCW
Device class
Class 2
Regulation
21 CFR 870.4875
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Colorado Springs, CO, US
Download summary PDFView on FDA.gov ↗

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More clearances from Spectranetics Corp.

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Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

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 K123632

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 K123632.

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