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)

P-S MEDICAL CSF ACCESS DEV 15MM/25MM

K-Number: K833822 · 1984-05-25

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1984-05-25
Product CodeLKG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

P-S MEDICAL CSF ACCESS DEV 15MM/25MM is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1984-05-25 under 510(k) number K833822. The device is classified under product code LKG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P-S MEDICAL CSF ACCESS DEV 15MM/25MM?

P-S MEDICAL CSF ACCESS DEV 15MM/25MM is a medical device that received FDA 510(k) clearance on 1984-05-25. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K833822.

When did P-S MEDICAL CSF ACCESS DEV 15MM/25MM receive FDA 510(k) clearance?

P-S MEDICAL CSF ACCESS DEV 15MM/25MM received FDA 510(k) clearance on 1984-05-25, under 510(k) number K833822.

Who is the listed applicant for P-S MEDICAL CSF ACCESS DEV 15MM/25MM?

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

What is the FDA product code for P-S MEDICAL CSF ACCESS DEV 15MM/25MM?

The FDA product code for P-S MEDICAL CSF ACCESS DEV 15MM/25MM is LKG.

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 Pudenz-Schulte Medical Research Corp. 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.

K960055MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932K954409PS MEDICAL IPI VASCULAR ACCESS CATHETERK951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITK934796IPI LOW PROFILE IMPORTK934167IPI DUAL LUMEN PORTK940096PS MEDICAL CATHETER PLACEMENT KIT

View all 40 devices →

Related Devices (Code: LKG)

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.

K950315CORDIS CSF RESERVOIRCordis Corp.K881690PORT-A-CATH PORTAL INTRODUCER FORCEPSPharmacia Deltec, Inc.K881493PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.Pharmacia Deltec, Inc.K874498CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.K874468P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.K833672HH SUBCUTANEOUS ACCESS PORTHolter-Hausner Intl.

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.

↑