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FDA 510(k)

STEERABLE GUIDE CATHETER

K-Number: K112239 · 2011-08-31

ApplicantAbbott Vascular
Decision Date2011-08-31
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STEERABLE GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2011-08-31 under 510(k) number K112239. 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 STEERABLE GUIDE CATHETER?

STEERABLE GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2011-08-31. The listed applicant is Abbott Vascular. The 510(k) number is K112239.

When did STEERABLE GUIDE CATHETER receive FDA 510(k) clearance?

STEERABLE GUIDE CATHETER received FDA 510(k) clearance on 2011-08-31, under 510(k) number K112239.

Who is the listed applicant for STEERABLE GUIDE CATHETER?

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

What is the FDA product code for STEERABLE GUIDE CATHETER?

The FDA product code for STEERABLE GUIDE CATHETER is DRA.

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Other records listing Abbott Vascular as applicant

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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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