FDA 510(k) K220075, Spartan Center Wire, by Spartan Micro, Inc.
FDA 510(k) K220075, Spartan Center Wire, by Spartan Micro, Inc.
Device Classification Name: Wire, Guide, Catheter
510(k) Number: K220075
Device Name: Spartan Center Wire
Applicant: Spartan Micro, Inc.
Regulation Number: 870.133
Classification Product Code: DQX
Date Received: 01/10/2022
Decision Date: 04/19/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 2,504
Fully redacted pages: 2,260
Content pages: 244
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