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510(k) K874096

TITANIUM GREENFIELD VENA CAVA FILTER CARRIER by Medi-Tech, Inc. — Product Code DTK

K874096 is an FDA 510(k) premarket notification submitted by Medi-Tech, Inc. for the device "TITANIUM GREENFIELD VENA CAVA FILTER CARRIER". The FDA issued a decision of Substantially Equivalent on November 4, 1988. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Medi-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1988
Date Received
October 8, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

Other clearances by Medi-Tech, Inc.

  • K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER (May 15, 1996)
  • K952345 — MEDI-TECH PLATFORM GUIDE CATHETER (August 17, 1995)
  • K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS (June 1, 1995)
  • K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (December 13, 1994)
  • K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (October 6, 1994)
  • K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLS (September 14, 1994)
  • K922990 — HEMODIALYSIS BATH (September 12, 1994)
  • K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (September 9, 1994)
  • K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL (October 22, 1990)
  • K895819 — MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (November 2, 1989)

Other clearances for product code DTK

  • K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E) (September 10, 2024)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (July 31, 2024)
  • K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK (June 26, 2024)
  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (February 29, 2024)
  • K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- (January 18, 2024)
  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (July 28, 2021)
  • K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (July 28, 2021)
  • K181202 — Sentry IVC Filter (June 6, 2018)
  • K173236 — Sentry IVC Filter (February 22, 2018)
  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (November 20, 2017)

FDA data resources