FDA 510(k)

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10

K-Number: K102176 · 2010-09-01

Decision Date2010-09-01

Product CodeDRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 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 2010-09-01 under 510(k) number K102176. 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 STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10?

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 is a medical device that received FDA 510(k) clearance on 2010-09-01. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K102176.

When did FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 receive FDA 510(k) clearance?

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 received FDA 510(k) clearance on 2010-09-01, under 510(k) number K102176.

Who is the listed applicant for FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10?

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 STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10?

The FDA product code for FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 is DRA.

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Other records listing Medtronic Cryocath, LP as applicant

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Related Devices (Code: DRA)

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation K250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation K232321FlexCath 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 Corporation K221397MitraClip 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.