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)

PARSET, MODEL A10001E

K-Number: K992104 · 1999-08-23

ApplicantRd Medical Mfg., Inc.
Decision Date1999-08-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PARSET, MODEL A10001E is the device name listed in this FDA 510(k) record. The listed applicant is Rd Medical Mfg., Inc.. It received FDA 510(k) clearance on 1999-08-23 under 510(k) number K992104. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARSET, MODEL A10001E?

PARSET, MODEL A10001E is a medical device that received FDA 510(k) clearance on 1999-08-23. The listed applicant is Rd Medical Mfg., Inc.. The 510(k) number is K992104.

When did PARSET, MODEL A10001E receive FDA 510(k) clearance?

PARSET, MODEL A10001E received FDA 510(k) clearance on 1999-08-23, under 510(k) number K992104.

Who is the listed applicant for PARSET, MODEL A10001E?

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

What is the FDA product code for PARSET, MODEL A10001E?

The FDA product code for PARSET, MODEL A10001E is FPA.

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 Rd Medical Mfg., 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.

K010538PARSET NEEDLELESS PRIMARY SET FOR BLUNT CANNULA, A10003E, PARSET NEEDLELESS SECONDARY SET WITH BLUNT CANNULA, A14003EK001102PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002EK000017PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

↑