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FDA 510(k)

Z FLEX-270TM STEERABLE SHEATH

K-Number: K112541 · 2012-02-07

ApplicantGreat Batch Medical
Decision Date2012-02-07
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Z FLEX-270TM STEERABLE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Great Batch Medical. It received FDA 510(k) clearance on 2012-02-07 under 510(k) number K112541. 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 Z FLEX-270TM STEERABLE SHEATH?

Z FLEX-270TM STEERABLE SHEATH is a medical device that received FDA 510(k) clearance on 2012-02-07. The listed applicant is Great Batch Medical. The 510(k) number is K112541.

When did Z FLEX-270TM STEERABLE SHEATH receive FDA 510(k) clearance?

Z FLEX-270TM STEERABLE SHEATH received FDA 510(k) clearance on 2012-02-07, under 510(k) number K112541.

Who is the listed applicant for Z FLEX-270TM STEERABLE SHEATH?

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

What is the FDA product code for Z FLEX-270TM STEERABLE SHEATH?

The FDA product code for Z FLEX-270TM STEERABLE SHEATH is DRA.

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Other records listing Great Batch Medical 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.

K181855RadialSeal Introducer KitK130559MOBICATH BI-DIRECTIONAL GUIDING SHEATHK122832MOBICATH TRANSSEPTAL NEEDLEK110051RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KITK111644MOBICATH TRANSSEPTAL NEEDLEK101784MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

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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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