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510(k) K021606

EN-SNARE ENDOVASCULAR SNARE AND CATHETER by Medical Device Technologies, Inc. — Product Code MMX

K021606 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "EN-SNARE ENDOVASCULAR SNARE AND CATHETER". The FDA issued a decision of Substantially Equivalent on May 31, 2002. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2002
Date Received
May 16, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Medical Device Technologies, Inc.

  • K101832 — BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT (August 27, 2010)
  • K053518 — INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (January 26, 2006)
  • K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR (August 30, 2005)
  • K050873 — CANALIZER HYDROPHILIC GUIDE WIRE (May 26, 2005)
  • K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE (February 11, 2005)
  • K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (September 30, 2004)
  • K040427 — FIBREX CATHETER PATENCY DEVICE (May 3, 2004)
  • K031442 — PBN GUIDEWIRES (August 13, 2003)
  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)
  • K000620 — PBN FALLOPIAN TUBE CATHETER SYSTEM (October 30, 2000)

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