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FDA 510(k)

VAXCEL PORT, MODELS 45-336 AND 45-338

K-Number: K032375 · 2003-08-19

Decision Date2003-08-19
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VAXCEL PORT, MODELS 45-336 AND 45-338 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 2003-08-19 under 510(k) number K032375. 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 PORT, MODELS 45-336 AND 45-338?

VAXCEL PORT, MODELS 45-336 AND 45-338 is a medical device that received FDA 510(k) clearance on 2003-08-19. The listed applicant is Boston Scientific Corp. The 510(k) number is K032375.

When did VAXCEL PORT, MODELS 45-336 AND 45-338 receive FDA 510(k) clearance?

VAXCEL PORT, MODELS 45-336 AND 45-338 received FDA 510(k) clearance on 2003-08-19, under 510(k) number K032375.

Who is the listed applicant for VAXCEL PORT, MODELS 45-336 AND 45-338?

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 PORT, MODELS 45-336 AND 45-338?

The FDA product code for VAXCEL PORT, MODELS 45-336 AND 45-338 is LJT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Boston Scientific Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LJT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.

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