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)

RENCTK

K-Number: K800774 · 1980-04-21

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1980-04-21
Product CodeCIB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RENCTK is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1980-04-21 under 510(k) number K800774. The device is classified under product code CIB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENCTK?

RENCTK is a medical device that received FDA 510(k) clearance on 1980-04-21. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K800774.

When did RENCTK receive FDA 510(k) clearance?

RENCTK received FDA 510(k) clearance on 1980-04-21, under 510(k) number K800774.

Who is the listed applicant for RENCTK?

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

What is the FDA product code for RENCTK?

The FDA product code for RENCTK is CIB.

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 Sorin Biomedica, Fiat, USA, 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.

K931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORSK925661STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULEK925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBEK925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMSK924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORK925541STOCKERT 1/4 BUBBLE SENSOR

View all 20 devices →

Related Devices (Code: CIB)

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.

K123763IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERSImmunodiagnostic Systems , Ltd.K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTDiaSorin, Inc.K062120CISBIO RENIN RIA TESTCis Bio InternationalK061758ACTIVE RENIN IRMADiagnostic Systems Laboratories, Inc.K011128NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)Nichols Institute DiagnosticsK981607ACTIVE RENIN IRMA MODEL NUMBER DSL-25100Diagnostic Systems Laboratories, 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.

↑