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)

GOLD CORE HF PRE SOLDER

K-Number: K002815 · 2000-12-19

ApplicantJeneric/Pentron, Inc.
Decision Date2000-12-19
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOLD CORE HF PRE SOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 2000-12-19 under 510(k) number K002815. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOLD CORE HF PRE SOLDER?

GOLD CORE HF PRE SOLDER is a medical device that received FDA 510(k) clearance on 2000-12-19. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K002815.

When did GOLD CORE HF PRE SOLDER receive FDA 510(k) clearance?

GOLD CORE HF PRE SOLDER received FDA 510(k) clearance on 2000-12-19, under 510(k) number K002815.

Who is the listed applicant for GOLD CORE HF PRE SOLDER?

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

What is the FDA product code for GOLD CORE HF PRE SOLDER?

The FDA product code for GOLD CORE HF PRE SOLDER is EJT.

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 Jeneric/Pentron, 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.

K020499BOND-3 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZER

View all 78 devices →

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,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.

↑