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FDA 510(k)

GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT

K-Number: K983927 · 1999-03-11

ApplicantArterial Vascular Engineering, Inc.
Decision Date1999-03-11
Product CodeDQT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT is the device name listed in this FDA 510(k) record. The listed applicant is Arterial Vascular Engineering, Inc.. It received FDA 510(k) clearance on 1999-03-11 under 510(k) number K983927. The device is classified under product code DQT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT?

GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT is a medical device that received FDA 510(k) clearance on 1999-03-11. The listed applicant is Arterial Vascular Engineering, Inc.. The 510(k) number is K983927.

When did GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT receive FDA 510(k) clearance?

GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT received FDA 510(k) clearance on 1999-03-11, under 510(k) number K983927.

Who is the listed applicant for GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT?

The FDA 510(k) record lists Arterial Vascular Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT?

The FDA product code for GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT is DQT.

Related Clinical Trials

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.

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Other records listing Arterial Vascular Engineering, 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.

K984627AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETERK971295AVE BRIDGE STENT SYSTEM

Related Devices (Code: DQT)

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.

K945963THE OMNIGUIDE GUIDING CATHETER WITH BALLOONMicro Interventional Systems, Inc.K910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERCathlab Corp.K910339AVD INTIMAX OCCLUSION CATHETERApplied Vascular Devices, Inc.K880860CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015Dlp, Inc.K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERIdeas For Medicine, Inc.K872090THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KITIdeas For Medicine, Inc.

Official Source

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