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FDA 510(k)

FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12

K-Number: K081049 · 2008-06-27

ApplicantCryocath Technologies, Inc.
Decision Date2008-06-27
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 is the device name listed in this FDA 510(k) record. The listed applicant is Cryocath Technologies, Inc.. It received FDA 510(k) clearance on 2008-06-27 under 510(k) number K081049. 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 & DILATOR, MODELS 3FC10, 3FC12?

FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 is a medical device that received FDA 510(k) clearance on 2008-06-27. The listed applicant is Cryocath Technologies, Inc.. The 510(k) number is K081049.

When did FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 receive FDA 510(k) clearance?

FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 received FDA 510(k) clearance on 2008-06-27, under 510(k) number K081049.

Who is the listed applicant for FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12?

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

What is the FDA product code for FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12?

The FDA product code for FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 is DRA.

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Other records listing Cryocath Technologies, Inc. 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.

K070357FLEXCATH STEERABLE SHEATH & DILATORK062140SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1K053436SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLEK040690SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLEK030303FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE

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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