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FDA 510(k)

SIMON NITINOL FILTER SYSTEM

K-Number: K963016 · 1996-11-18

ApplicantNitinol Medical Technologies, Inc.
Decision Date1996-11-18
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIMON NITINOL FILTER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nitinol Medical Technologies, Inc.. It received FDA 510(k) clearance on 1996-11-18 under 510(k) number K963016. 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 SIMON NITINOL FILTER SYSTEM?

SIMON NITINOL FILTER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-18. The listed applicant is Nitinol Medical Technologies, Inc.. The 510(k) number is K963016.

When did SIMON NITINOL FILTER SYSTEM receive FDA 510(k) clearance?

SIMON NITINOL FILTER SYSTEM received FDA 510(k) clearance on 1996-11-18, under 510(k) number K963016.

Who is the listed applicant for SIMON NITINOL FILTER SYSTEM?

The FDA 510(k) record lists Nitinol Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMON NITINOL FILTER SYSTEM?

The FDA product code for SIMON NITINOL FILTER SYSTEM is DTK.

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Other records listing Nitinol Medical Technologies, Inc. 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.

K970099SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMK963014SIMON NITINOL FILTER/STRAIGHT LINE SYSTEMK944353SIMON NITINOL FILTERK940489SIMON NITINOL FILTERK912144SIMON NITINOL FILTER, MODIFICATIONK894703SIMON NITINOL FILTER

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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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