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FDA 510(k) Application Details - K221986
Device Classification Name
More FDA Info for this Device
510(K) Number
K221986
Device Name
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Applicant
Transit Scientific, LLC
2757 South 300 West, Suite E
Salt Lake City, UT 84115 US
Other 510(k) Applications for this Company
Contact
Jennifer Arnold
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/06/2022
Decision Date
10/18/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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