FDA 510(k)

VAXCEL WITH PASV PORT, MODEL 45-213

K-Number: K032008 · 2003-07-14

Decision Date2003-07-14

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VAXCEL WITH PASV PORT, MODEL 45-213 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2003-07-14 under 510(k) number K032008. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAXCEL WITH PASV PORT, MODEL 45-213?

VAXCEL WITH PASV PORT, MODEL 45-213 is a medical device that received FDA 510(k) clearance on 2003-07-14. The listed applicant is Boston Scientific Corp. The 510(k) number is K032008.

When did VAXCEL WITH PASV PORT, MODEL 45-213 receive FDA 510(k) clearance?

VAXCEL WITH PASV PORT, MODEL 45-213 received FDA 510(k) clearance on 2003-07-14, under 510(k) number K032008.

Who is the listed applicant for VAXCEL WITH PASV PORT, MODEL 45-213?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAXCEL WITH PASV PORT, MODEL 45-213?

The FDA product code for VAXCEL WITH PASV PORT, MODEL 45-213 is LJT.

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Related Devices (Code: LJT)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.