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FDA 510(k)

REFLEXION SPIRAL VARIABLE RADIUS CATHETER

K-Number: K072012 · 2007-08-22

ApplicantSt Jude Medical
Decision Date2007-08-22
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REFLEXION SPIRAL VARIABLE RADIUS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2007-08-22 under 510(k) number K072012. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFLEXION SPIRAL VARIABLE RADIUS CATHETER?

REFLEXION SPIRAL VARIABLE RADIUS CATHETER is a medical device that received FDA 510(k) clearance on 2007-08-22. The listed applicant is St Jude Medical. The 510(k) number is K072012.

When did REFLEXION SPIRAL VARIABLE RADIUS CATHETER receive FDA 510(k) clearance?

REFLEXION SPIRAL VARIABLE RADIUS CATHETER received FDA 510(k) clearance on 2007-08-22, under 510(k) number K072012.

Who is the listed applicant for REFLEXION SPIRAL VARIABLE RADIUS CATHETER?

The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLEXION SPIRAL VARIABLE RADIUS CATHETER?

The FDA product code for REFLEXION SPIRAL VARIABLE RADIUS CATHETER is DRF.

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Related Devices (Code: DRF)

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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