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FDA 510(k)

LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN

K-Number: K052575 · 2006-01-19

ApplicantSt Jude Medical
Decision Date2006-01-19
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN 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 2006-01-19 under 510(k) number K052575. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN?

LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN is a medical device that received FDA 510(k) clearance on 2006-01-19. The listed applicant is St Jude Medical. The 510(k) number is K052575.

When did LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN receive FDA 510(k) clearance?

LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN received FDA 510(k) clearance on 2006-01-19, under 510(k) number K052575.

Who is the listed applicant for LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN?

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 LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN?

The FDA product code for LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN is DRA.

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Related Devices (Code: DRA)

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.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL

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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