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FDA 510(k)

AIS ANGIOSCOPE

K-Number: K871492 · 1987-09-14

ApplicantAdvanced Interventional Systems, Inc.
Decision Date1987-09-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AIS ANGIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Interventional Systems, Inc.. It received FDA 510(k) clearance on 1987-09-14 under 510(k) number K871492. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIS ANGIOSCOPE?

AIS ANGIOSCOPE is a medical device that received FDA 510(k) clearance on 1987-09-14. The listed applicant is Advanced Interventional Systems, Inc.. The 510(k) number is K871492.

When did AIS ANGIOSCOPE receive FDA 510(k) clearance?

AIS ANGIOSCOPE received FDA 510(k) clearance on 1987-09-14, under 510(k) number K871492.

Who is the listed applicant for AIS ANGIOSCOPE?

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

What is the FDA product code for AIS ANGIOSCOPE?

The FDA product code for AIS ANGIOSCOPE is DQX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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