FDA 510(k)

VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM

K-Number: K982888 · 1998-10-20

Decision Date1998-10-20

Product CodeLJT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM 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 1998-10-20 under 510(k) number K982888. 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 IMPANTABLE VASCULAR ACCESS SYSTEM?

VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-20. The listed applicant is Boston Scientific Corp. The 510(k) number is K982888.

When did VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM receive FDA 510(k) clearance?

VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM received FDA 510(k) clearance on 1998-10-20, under 510(k) number K982888.

Who is the listed applicant for VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM?

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 IMPANTABLE VASCULAR ACCESS SYSTEM?

The FDA product code for VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM is 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.