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FDA 510(k)

MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST

K-Number: K100789 · 2010-04-21

ApplicantEvalve, Inc.
Decision Date2010-04-21
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST is the device name listed in this FDA 510(k) record. The listed applicant is Evalve, Inc.. It received FDA 510(k) clearance on 2010-04-21 under 510(k) number K100789. 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 MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST?

MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST is a medical device that received FDA 510(k) clearance on 2010-04-21. The listed applicant is Evalve, Inc.. The 510(k) number is K100789.

When did MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST receive FDA 510(k) clearance?

MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST received FDA 510(k) clearance on 2010-04-21, under 510(k) number K100789.

Who is the listed applicant for MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST?

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 MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST?

The FDA product code for MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST 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.

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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.

K093866EVALVE STEERABLE GUIDE CATHETERK091596EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01STK083793STEERABLE GUIDE CATHETER

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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