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FDA 510(k)

STEERABLE GUIDE CATHETER

K-Number: K083793 · 2009-04-27

ApplicantEvalve, Inc.
Decision Date2009-04-27
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 Evalve, Inc.. It received FDA 510(k) clearance on 2009-04-27 under 510(k) number K083793. 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 2009-04-27. The listed applicant is Evalve, Inc.. The 510(k) number is K083793.

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

STEERABLE GUIDE CATHETER received FDA 510(k) clearance on 2009-04-27, under 510(k) number K083793.

Who is the listed applicant for STEERABLE GUIDE CATHETER?

The FDA 510(k) record lists Evalve, Inc. 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.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Evalve, 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.

K100789MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01STK093866EVALVE STEERABLE GUIDE CATHETERK091596EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST

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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