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510(k) K771046

VENA CAVA UMBRELLA FILTER, MODEL 7321 by Edwards Laboratories — Product Code DTK

K771046 is an FDA 510(k) premarket notification submitted by Edwards Laboratories for the device "VENA CAVA UMBRELLA FILTER, MODEL 7321". The FDA issued a decision of Substantially Equivalent on June 22, 1977. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1977
Date Received
June 10, 1977
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 Edwards Laboratories

  • K801552 — MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR (July 28, 1980)
  • K800655 — MODEL 100 SPECTRAVIEW (April 16, 1980)
  • K792441 — CARPENTIER-EDWARDS FLEX. ANNULOPLASTY (March 17, 1980)
  • K792034 — INTEGRAL DISPOSABLE HOLDER CARPENTIER (December 7, 1979)
  • K790047 — CARDIAC OUTPUT COMPUTER, MDEL 9520A (February 26, 1979)
  • K790022 — DISPOSABLE HOLDER FOR BIOPROSTHESIS (January 15, 1979)
  • K781535 — AC ADAPTER:MODELS 9525,9526,9527 (September 15, 1978)
  • K771663 — PROBE & CATHETER (September 20, 1977)
  • K760151 — APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN) (August 26, 1976)
  • K760192 — COMPUTER, THERMODILUTION CARDIAC (9520) (July 19, 1976)

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)
  • K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena (November 20, 2017)

FDA data resources