Home / 510(k) Clearances / K213666

510(k) K213666

NuCath Wedge Pressure Catheter by Pfm Medical, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2022
Date Received
November 22, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Pfm Medical, Inc.

  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)
  • K241278 — ASEPT® Glide Peritoneal Drainage System (January 14, 2025)
  • K221779 — ASEPT Peritoneal Drainage System (May 2, 2023)
  • K201137 — Asept Surgical Face Mask (August 19, 2020)
  • K192802 — primeMidline Catheters (October 28, 2019)
  • K173114 — primeMidline Catheters (March 7, 2018)
  • K140137 — SAFETY BIOPSY NEEDLE SYSTEM (March 25, 2014)
  • K122402 — LPP (LOW PROFILE PORT) (July 16, 2013)
  • K113354 — VETA PERITONEAL DIALYSIS CATHETER (March 13, 2012)
  • K110914 — TRIPLE LUMEN PFM PICC (September 21, 2011)

Other clearances for product code DQO

  • K250751 — DualView Catheter (July 17, 2025)
  • K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (January 31, 2025)
  • K242420 — pNOVUS 21 Microcatheter (November 12, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
  • K232573 — INFINITI™ Ambi Angiographic Catheter (November 21, 2023)
  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)
  • K230411 — Dragonfly OpStar™ Imaging Catheter (April 14, 2023)