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510(k) K011557

PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS by NuMED, Inc. — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2001
Date Received
May 21, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

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  • K122012 — Z-MED Z-MED II (October 4, 2012)

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  • K240900 — HOTWIRE™ RF Guidewire (May 1, 2024)
  • K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (October 12, 2023)
  • K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Cathet (August 22, 2022)