FDA 510(k)

A-V FISTULA NEEDLE

K-Number: K781331 · 1978-08-17

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1978-08-17

Product CodeDJC

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

A-V FISTULA NEEDLE 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 1978-08-17 under 510(k) number K781331. The device is classified under product code DJC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-V FISTULA NEEDLE?

A-V FISTULA NEEDLE is a medical device that received FDA 510(k) clearance on 1978-08-17. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K781331.

When did A-V FISTULA NEEDLE receive FDA 510(k) clearance?

A-V FISTULA NEEDLE received FDA 510(k) clearance on 1978-08-17, under 510(k) number K781331.

Who is the listed applicant for A-V FISTULA NEEDLE?

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 A-V FISTULA NEEDLE?

The FDA product code for A-V FISTULA NEEDLE is DJC.

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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.