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)

SPIVE NEEDLE SYSTEM, MODIFICATION

K-Number: K904013 · 1990-10-01

ApplicantPascall Medical Corp.
Decision Date1990-10-01
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPIVE NEEDLE SYSTEM, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Pascall Medical Corp.. It received FDA 510(k) clearance on 1990-10-01 under 510(k) number K904013. 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 SPIVE NEEDLE SYSTEM, MODIFICATION?

SPIVE NEEDLE SYSTEM, MODIFICATION is a medical device that received FDA 510(k) clearance on 1990-10-01. The listed applicant is Pascall Medical Corp.. The 510(k) number is K904013.

When did SPIVE NEEDLE SYSTEM, MODIFICATION receive FDA 510(k) clearance?

SPIVE NEEDLE SYSTEM, MODIFICATION received FDA 510(k) clearance on 1990-10-01, under 510(k) number K904013.

Who is the listed applicant for SPIVE NEEDLE SYSTEM, MODIFICATION?

The FDA 510(k) record lists Pascall Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIVE NEEDLE SYSTEM, MODIFICATION?

The FDA product code for SPIVE NEEDLE SYSTEM, MODIFICATION 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

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.

↑