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FDA 510(k)

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER

K-Number: K082075 · 2008-08-15

ApplicantHansen Medical, Inc.
Decision Date2008-08-15
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER 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 2008-08-15 under 510(k) number K082075. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER?

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER is a medical device that received FDA 510(k) clearance on 2008-08-15. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K082075.

When did HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER receive FDA 510(k) clearance?

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER received FDA 510(k) clearance on 2008-08-15, under 510(k) number K082075.

Who is the listed applicant for HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER?

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 DILATOR FOR ARTISAN CONTROL CATHETER?

The FDA product code for HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER is DRE.

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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: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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