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FDA 510(k)

ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)

K-Number: K881088 · 1988-05-31

ApplicantDevices For Vascular Intervention, Inc.
Decision Date1988-05-31
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Devices For Vascular Intervention, Inc.. It received FDA 510(k) clearance on 1988-05-31 under 510(k) number K881088. 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 ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)?

ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) is a medical device that received FDA 510(k) clearance on 1988-05-31. The listed applicant is Devices For Vascular Intervention, Inc.. The 510(k) number is K881088.

When did ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) receive FDA 510(k) clearance?

ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) received FDA 510(k) clearance on 1988-05-31, under 510(k) number K881088.

Who is the listed applicant for ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)?

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

What is the FDA product code for ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)?

The FDA product code for ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM) is LIT.

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Other records listing Devices For Vascular Intervention, Inc. as applicant

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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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