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FDA 510(k)

EXCELSIOR 1018 MICROCATHETER

K-Number: K994155 · 2000-08-03

ApplicantBoston Scientific, Target
Decision Date2000-08-03
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXCELSIOR 1018 MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific, Target. It received FDA 510(k) clearance on 2000-08-03 under 510(k) number K994155. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELSIOR 1018 MICROCATHETER?

EXCELSIOR 1018 MICROCATHETER is a medical device that received FDA 510(k) clearance on 2000-08-03. The listed applicant is Boston Scientific, Target. The 510(k) number is K994155.

When did EXCELSIOR 1018 MICROCATHETER receive FDA 510(k) clearance?

EXCELSIOR 1018 MICROCATHETER received FDA 510(k) clearance on 2000-08-03, under 510(k) number K994155.

Who is the listed applicant for EXCELSIOR 1018 MICROCATHETER?

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

What is the FDA product code for EXCELSIOR 1018 MICROCATHETER?

The FDA product code for EXCELSIOR 1018 MICROCATHETER is KRA.

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Related Devices (Code: KRA)

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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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.

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