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510(k) K220410

Ebony HP PTA OTW 0.035 Catheter by Natec Medical , Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2022
Date Received
February 14, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Natec Medical , Ltd.

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  • K143041 — Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Cathe (June 4, 2015)
  • K143036 — Ebony PTA 0.035 Peripheral Dilatation Catheter (March 30, 2015)
  • K142459 — Ebony PTA 0.014 RX Peripheral Dilatation Catheter (February 3, 2015)
  • K112735 — TAMARIN BLUE PTCA RX DILATATION CATHETER (November 2, 2012)
  • K112513 — EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER (December 9, 2011)

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