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FDA 510(k)

LINASYS

K-Number: K071063 · 2007-12-20

ApplicantPathfinder Therapeutics, Inc.
Decision Date2007-12-20
Product CodeOEW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LINASYS is the device name listed in this FDA 510(k) record. The listed applicant is Pathfinder Therapeutics, Inc.. It received FDA 510(k) clearance on 2007-12-20 under 510(k) number K071063. The device is classified under product code OEW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINASYS?

LINASYS is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Pathfinder Therapeutics, Inc.. The 510(k) number is K071063.

When did LINASYS receive FDA 510(k) clearance?

LINASYS received FDA 510(k) clearance on 2007-12-20, under 510(k) number K071063.

Who is the listed applicant for LINASYS?

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

What is the FDA product code for LINASYS?

The FDA product code for LINASYS is OEW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pathfinder Therapeutics, 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.

K101979EXPLORER LIVER (PASSIVE TRACKING)K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEMK082228PLANISIGHT LINASYS

Related Devices (Code: OEW)

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.

K101979EXPLORER LIVER (PASSIVE TRACKING)Pathfinder Therapeutics, Inc.K093494LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEMPathfinder Therapeutics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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