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FDA 510(k)

AVE ALLIANCE DILATATION CATHETER

K-Number: K931384 · 1993-09-17

ApplicantApplied Vascular Engineering, Inc.
Decision Date1993-09-17
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AVE ALLIANCE DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Engineering, Inc.. It received FDA 510(k) clearance on 1993-09-17 under 510(k) number K931384. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVE ALLIANCE DILATATION CATHETER?

AVE ALLIANCE DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 1993-09-17. The listed applicant is Applied Vascular Engineering, Inc.. The 510(k) number is K931384.

When did AVE ALLIANCE DILATATION CATHETER receive FDA 510(k) clearance?

AVE ALLIANCE DILATATION CATHETER received FDA 510(k) clearance on 1993-09-17, under 510(k) number K931384.

Who is the listed applicant for AVE ALLIANCE DILATATION CATHETER?

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

What is the FDA product code for AVE ALLIANCE DILATATION CATHETER?

The FDA product code for AVE ALLIANCE DILATATION CATHETER is LIT.

Related Clinical Trials

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Related Devices (Code: LIT)

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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Official Source

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