Atlas FDA

LLD EZ

FDA 510(k) clearance K142116 · decided 2014-08-12

Clearance details

K-number
K142116
Device name
LLD EZ
Applicant
Spectranetics, Inc.
Decision
Substantially Equivalent
Date received
2014-08-04
Decision date
2014-08-12
Days to decision
8 days
Clearance type
Special
Product code
DRB
Device class
2
Regulation number
870.1380
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Colorado Springs, CO, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.