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SLS II Laser Sheath

Spectranetics Corporation · Model 500-001 · UDI-DI 00813132020293

MFA Prescription
0
510(k) clearances
1,561
Adverse events (510 deaths)
0
Recalls
4
Facilities

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.