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510(k) K000620

PBN FALLOPIAN TUBE CATHETER SYSTEM by Medical Device Technologies, Inc. — Product Code MDG

K000620 is an FDA 510(k) premarket notification submitted by Medical Device Technologies, Inc. for the device "PBN FALLOPIAN TUBE CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 2000. The device falls under product code MDG (System, Intrafallopian Cannula), a Class II device regulated under 21 CFR 884.4530. Medical Device Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2000
Date Received
February 24, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Intrafallopian Cannula
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
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)
  • K021606 — EN-SNARE ENDOVASCULAR SNARE AND CATHETER (May 31, 2002)
  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)

FDA data resources