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FDA 510(k)

HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR

K-Number: K061070 · 2006-10-13

ApplicantHansen Medical, Inc.
Decision Date2006-10-13
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hansen Medical, Inc.. It received FDA 510(k) clearance on 2006-10-13 under 510(k) number K061070. 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 HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR?

HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K061070.

When did HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR receive FDA 510(k) clearance?

HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR received FDA 510(k) clearance on 2006-10-13, under 510(k) number K061070.

Who is the listed applicant for HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR?

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

What is the FDA product code for HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR?

The FDA product code for HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR is DRC.

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Other records listing Hansen Medical, 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.

K160919Hansen Medical Magellan Robotic Catheter 9FrK153304Hansen Medical Magellan Robotic Catheter eKitK132369MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRK111004HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERK102168SENSEI X ROBOTIC CATHETER SYSTEMK091808SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057

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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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