FDA Device Intelligence
HomeDevice types › LPC

Device, Angioplasty, Laser, Coronary

FDA product code LPC · Class 3 · Unknown

32
Registered devices
298
Adverse events
4
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-10-14Spectranetics CorporationLaser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proc
2022-06-01Spectranetics CorporationThe LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until cod
2016-10-31Spectranetics CorporationSpectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion
2012-03-13Spectranetics Corp.Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.