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FDA 510(k)

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)

K-Number: K123591 · 2012-12-27

ApplicantMedtronic Cryocath, LP
Decision Date2012-12-27
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cryocath, LP. It received FDA 510(k) clearance on 2012-12-27 under 510(k) number K123591. 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 FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)?

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) is a medical device that received FDA 510(k) clearance on 2012-12-27. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K123591.

When did FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) receive FDA 510(k) clearance?

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) received FDA 510(k) clearance on 2012-12-27, under 510(k) number K123591.

Who is the listed applicant for FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)?

The FDA 510(k) record lists Medtronic Cryocath, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)?

The FDA product code for FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) is DRA.

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Other records listing Medtronic Cryocath, LP 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.

K202620FlexCath Advance Steerable Sheath and DilatorK183174FlexCath Advance Steerable Sheath and DilatorK163268FlexCath Select Steerable Shealth and DilatorK102176FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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