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FDA 510(k)

POLY-TAC

K-Number: K882235 · 1988-10-05

ApplicantCardiovascular Group, Inc.
Decision Date1988-10-05
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLY-TAC is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Group, Inc.. It received FDA 510(k) clearance on 1988-10-05 under 510(k) number K882235. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-TAC?

POLY-TAC is a medical device that received FDA 510(k) clearance on 1988-10-05. The listed applicant is Cardiovascular Group, Inc.. The 510(k) number is K882235.

When did POLY-TAC receive FDA 510(k) clearance?

POLY-TAC received FDA 510(k) clearance on 1988-10-05, under 510(k) number K882235.

Who is the listed applicant for POLY-TAC?

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

What is the FDA product code for POLY-TAC?

The FDA product code for POLY-TAC is LDD.

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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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