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FDA 510(k)

MOBICATH TRANSSEPTAL NEEDLE

K-Number: K111644 · 2011-10-03

ApplicantGreat Batch Medical
Decision Date2011-10-03
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBICATH TRANSSEPTAL NEEDLE 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 2011-10-03 under 510(k) number K111644. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOBICATH TRANSSEPTAL NEEDLE?

MOBICATH TRANSSEPTAL NEEDLE is a medical device that received FDA 510(k) clearance on 2011-10-03. The listed applicant is Great Batch Medical. The 510(k) number is K111644.

When did MOBICATH TRANSSEPTAL NEEDLE receive FDA 510(k) clearance?

MOBICATH TRANSSEPTAL NEEDLE received FDA 510(k) clearance on 2011-10-03, under 510(k) number K111644.

Who is the listed applicant for MOBICATH TRANSSEPTAL NEEDLE?

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 MOBICATH TRANSSEPTAL NEEDLE?

The FDA product code for MOBICATH TRANSSEPTAL NEEDLE is DRC.

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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 NEEDLEK112541Z FLEX-270TM STEERABLE SHEATHK110051RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KITK101784MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

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Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC

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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