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510(k) K200629

Aspire Mechanical Aspirator G by Control Medical Technology — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
March 10, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Control Medical Technology

  • K200871 — Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirato (May 4, 2020)
  • K131998 — ASPIRE RX-LP6 ASPIRATION CATHETER (November 26, 2013)
  • K113757 — ASPIRE MAX ASPIRATION CATHETER (February 22, 2012)

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