FDA 510(k)

PIVOT STEERABLE MICROCATHETER

K-Number: K050630 · 2005-03-22

ApplicantBoston Scientific - Precision Vascular

Decision Date2005-03-22

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PIVOT STEERABLE MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific - Precision Vascular. It received FDA 510(k) clearance on 2005-03-22 under 510(k) number K050630. 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 PIVOT STEERABLE MICROCATHETER?

PIVOT STEERABLE MICROCATHETER is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Boston Scientific - Precision Vascular. The 510(k) number is K050630.

When did PIVOT STEERABLE MICROCATHETER receive FDA 510(k) clearance?

PIVOT STEERABLE MICROCATHETER received FDA 510(k) clearance on 2005-03-22, under 510(k) number K050630.

Who is the listed applicant for PIVOT STEERABLE MICROCATHETER?

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

What is the FDA product code for PIVOT STEERABLE MICROCATHETER?

The FDA product code for PIVOT STEERABLE MICROCATHETER is KRA.

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Other records listing Boston Scientific - Precision Vascular as applicant

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Related Devices (Code: KRA)

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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.