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FDA 510(k)

RENEGADE HI-FLO MICROCATHETER

K-Number: K000177 · 2000-04-07

Decision Date2000-04-07
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RENEGADE HI-FLO MICROCATHETER 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 2000-04-07 under 510(k) number K000177. 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 RENEGADE HI-FLO MICROCATHETER?

RENEGADE HI-FLO MICROCATHETER is a medical device that received FDA 510(k) clearance on 2000-04-07. The listed applicant is Boston Scientific Corp. The 510(k) number is K000177.

When did RENEGADE HI-FLO MICROCATHETER receive FDA 510(k) clearance?

RENEGADE HI-FLO MICROCATHETER received FDA 510(k) clearance on 2000-04-07, under 510(k) number K000177.

Who is the listed applicant for RENEGADE HI-FLO MICROCATHETER?

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 RENEGADE HI-FLO MICROCATHETER?

The FDA product code for RENEGADE HI-FLO MICROCATHETER is KRA.

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: 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.

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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