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FDA 510(k)

FOXCROSS PTA CATHETER

K-Number: K081417 · 2008-06-04

ApplicantAbbott Vascular, Inc.
Decision Date2008-06-04
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOXCROSS PTA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular, Inc.. It received FDA 510(k) clearance on 2008-06-04 under 510(k) number K081417. 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 FOXCROSS PTA CATHETER?

FOXCROSS PTA CATHETER is a medical device that received FDA 510(k) clearance on 2008-06-04. The listed applicant is Abbott Vascular, Inc.. The 510(k) number is K081417.

When did FOXCROSS PTA CATHETER receive FDA 510(k) clearance?

FOXCROSS PTA CATHETER received FDA 510(k) clearance on 2008-06-04, under 510(k) number K081417.

Who is the listed applicant for FOXCROSS PTA CATHETER?

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

What is the FDA product code for FOXCROSS PTA CATHETER?

The FDA product code for FOXCROSS PTA CATHETER is LIT.

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Other records listing Abbott Vascular, 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.

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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

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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