Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C-THV SYSTEM

K-Number: K113594 · 2012-03-02

ApplicantPaieon, Inc.
Decision Date2012-03-02
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

C-THV SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Paieon, Inc.. It received FDA 510(k) clearance on 2012-03-02 under 510(k) number K113594. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-THV SYSTEM?

C-THV SYSTEM is a medical device that received FDA 510(k) clearance on 2012-03-02. The listed applicant is Paieon, Inc.. The 510(k) number is K113594.

When did C-THV SYSTEM receive FDA 510(k) clearance?

C-THV SYSTEM received FDA 510(k) clearance on 2012-03-02, under 510(k) number K113594.

Who is the listed applicant for C-THV SYSTEM?

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

What is the FDA product code for C-THV SYSTEM?

The FDA product code for C-THV SYSTEM is IZI.

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 Paieon, 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.

K120282CARDNAVK110256THE IC-PRO SYSTEMK083745THE IC-PRO SYSTEM, MODEL VERSION 3.2K082907IC-PRO SYSTEM, VERSION 3.1.0.4K073328CARDIOP-B SYSTEM, VERSION 2.1 WITH LVAK072591CARDIOP-B SYSTEM, VERSION 2.1

View all 8 devices →

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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.

↑