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510(k) K141933

FILAO NC RX PTCA DILATATION CATHETER by Natec Medical , Ltd. — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2015
Date Received
July 16, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class
Class II
Regulation Number
870.5100
Review Panel
CV
Submission Type

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

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  • K143036 — Ebony PTA 0.035 Peripheral Dilatation Catheter (March 30, 2015)
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  • 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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  • K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon (May 31, 2024)
  • K223189 — Firefighter™ NC Pro PTCA Balloon Catheter (July 21, 2023)
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