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510(k) K210012

Tamarin Blue PTCA RX Dilatation Catheter by Natec Medical , Ltd. — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2021
Date Received
January 4, 2021
Clearance Type
Special
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.

Other clearances by Natec Medical , Ltd.

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  • K152230 — Ebony PTA .014 RX Pheripheral Dilatation Catheter (September 3, 2015)
  • K141933 — FILAO NC RX PTCA DILATATION CATHETER (June 28, 2015)
  • 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)

Other clearances for product code LOX

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  • K233505 — Sapphire ULTRA Coronary Dilatation Catheter (August 15, 2024)
  • 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)
  • K230374 — Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Ballo (June 29, 2023)
  • K230705 — POT PTCA Balloon Dilatation Catheter (April 11, 2023)
  • K223022 — SC HONKYTONK PTCA Balloon Dilatation Catheter (February 15, 2023)
  • K222538 — NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter (December 21, 2022)