FDA 510(k)

ACS INDEFLATOR P/T 20

K-Number: K883452 · 1988-10-14

ApplicantAdvanced Cardiovascular Systems, Inc.

Decision Date1988-10-14

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACS INDEFLATOR P/T 20 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 1988-10-14 under 510(k) number K883452. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS INDEFLATOR P/T 20?

ACS INDEFLATOR P/T 20 is a medical device that received FDA 510(k) clearance on 1988-10-14. The listed applicant is Advanced Cardiovascular Systems, Inc.. The 510(k) number is K883452.

When did ACS INDEFLATOR P/T 20 receive FDA 510(k) clearance?

ACS INDEFLATOR P/T 20 received FDA 510(k) clearance on 1988-10-14, under 510(k) number K883452.

Who is the listed applicant for ACS INDEFLATOR P/T 20?

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

What is the FDA product code for ACS INDEFLATOR P/T 20?

The FDA product code for ACS INDEFLATOR P/T 20 is DXT.

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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.