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FDA 510(k)

VENA CAVA UMBRELLA FILTER, MODEL 7321

K-Number: K771046 · 1977-06-22

ApplicantEdwards Laboratories
Decision Date1977-06-22
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENA CAVA UMBRELLA FILTER, MODEL 7321 is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Laboratories. It received FDA 510(k) clearance on 1977-06-22 under 510(k) number K771046. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENA CAVA UMBRELLA FILTER, MODEL 7321?

VENA CAVA UMBRELLA FILTER, MODEL 7321 is a medical device that received FDA 510(k) clearance on 1977-06-22. The listed applicant is Edwards Laboratories. The 510(k) number is K771046.

When did VENA CAVA UMBRELLA FILTER, MODEL 7321 receive FDA 510(k) clearance?

VENA CAVA UMBRELLA FILTER, MODEL 7321 received FDA 510(k) clearance on 1977-06-22, under 510(k) number K771046.

Who is the listed applicant for VENA CAVA UMBRELLA FILTER, MODEL 7321?

The FDA 510(k) record lists Edwards Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENA CAVA UMBRELLA FILTER, MODEL 7321?

The FDA product code for VENA CAVA UMBRELLA FILTER, MODEL 7321 is DTK.

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Other records listing Edwards Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSORK800655MODEL 100 SPECTRAVIEWK792441CARPENTIER-EDWARDS FLEX. ANNULOPLASTYK792034INTEGRAL DISPOSABLE HOLDER CARPENTIERK790047CARDIAC OUTPUT COMPUTER, MDEL 9520AK790022DISPOSABLE HOLDER FOR BIOPROSTHESIS

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Related Devices (Code: DTK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBdK233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterWilliam Cook Europe ApsK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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