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510(k) K033188

TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 by Idev Technologies, Inc. — Product Code MMX

K033188 is an FDA 510(k) premarket notification submitted by Idev Technologies, Inc. for the device "TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050". The FDA issued a decision of Substantially Equivalent on November 19, 2003. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Idev Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2003
Date Received
October 1, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous Retrieval
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Idev Technologies, Inc.

  • K130591 — SUPERA VERITAS (May 2, 2013)
  • K122546 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYST (December 7, 2012)
  • K111627 — SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY S (August 21, 2012)
  • K111766 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTE (October 19, 2011)
  • K093893 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYST (October 5, 2010)
  • K071646 — SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL (January 31, 2008)
  • K060557 — SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS0 (August 15, 2006)
  • K050926 — TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 (May 9, 2005)
  • K041374 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 (March 2, 2005)
  • K030504 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 (September 16, 2003)

Other clearances for product code MMX

  • K242776 — LimFlow V-Ceiver (February 14, 2025)
  • K241259 — Amplatz Goose Neck Snare Kit (June 3, 2024)
  • K232443 — Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (September 7, 2023)
  • K222254 — Gunther Tulip Vena Cava Filter Retrieval Set (May 16, 2023)
  • K222083 — LimFlow V-Ceiver (August 9, 2022)
  • K212988 — ONO Retrieval Device (May 23, 2022)
  • K213494 — Aveir Retrieval Catheter (April 1, 2022)
  • K200963 — Halo Single-Loop Microsnare Kit (January 5, 2021)
  • K200268 — Halo™ Single-Loop Snare Kit (June 3, 2020)
  • K193507 — Merit ONE Snare System (January 17, 2020)

FDA data resources