FDA 510(k)

VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM

K-Number: K945458 · 1995-02-06

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic

Decision Date1995-02-06

Product CodeGIM

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM 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 1995-02-06 under 510(k) number K945458. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM?

VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1995-02-06. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K945458.

When did VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM receive FDA 510(k) clearance?

VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM received FDA 510(k) clearance on 1995-02-06, under 510(k) number K945458.

Who is the listed applicant for VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM?

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 VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM?

The FDA product code for VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM is GIM.

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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.