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FDA 510(k)

MODIFIED PCA INFUSER

K-Number: K875364 · 1988-04-13

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1988-04-13
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED PCA INFUSER is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K875364. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED PCA INFUSER?

MODIFIED PCA INFUSER is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K875364.

When did MODIFIED PCA INFUSER receive FDA 510(k) clearance?

MODIFIED PCA INFUSER received FDA 510(k) clearance on 1988-04-13, under 510(k) number K875364.

Who is the listed applicant for MODIFIED PCA INFUSER?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED PCA INFUSER?

The FDA product code for MODIFIED PCA INFUSER is FRN.

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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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