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FDA 510(k)

DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS

K-Number: K132947 · 2013-10-18

ApplicantBoston Scientific Corp
Decision Date2013-10-18
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS 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 2013-10-18 under 510(k) number K132947. 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 DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS?

DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS is a medical device that received FDA 510(k) clearance on 2013-10-18. The listed applicant is Boston Scientific Corp. The 510(k) number is K132947.

When did DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS receive FDA 510(k) clearance?

DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS received FDA 510(k) clearance on 2013-10-18, under 510(k) number K132947.

Who is the listed applicant for DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS?

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 DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS?

The FDA product code for DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS 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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