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)

SPLIT CATH III

K-Number: K111651 · 2011-12-08

ApplicantMedical Components, Inc.
Decision Date2011-12-08
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

SPLIT CATH III is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2011-12-08 under 510(k) number K111651. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SPLIT CATH III?

SPLIT CATH III is a medical device that received FDA 510(k) clearance on 2011-12-08. The listed applicant is Medical Components, Inc.. The 510(k) number is K111651.

When did SPLIT CATH III receive FDA 510(k) clearance?

SPLIT CATH III received FDA 510(k) clearance on 2011-12-08, under 510(k) number K111651.

Who is the listed applicant for SPLIT CATH III?

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

What is the FDA product code for SPLIT CATH III?

The FDA product code for SPLIT CATH III is MSD.

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 Medical Components, 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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterK1316876F X 60CM TRIPLE PRO-LINE CT BASIC IR SETK1306872F & 3F VASCU-SHEATH TEARAWAY INTRODUCERK1309235F DIGNITY CT TITANIUM PORTK124046VALVED TEARAWAY INTRODUCER GENERATION IIK1236173F PRO-PICC

View all 61 devices →

Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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.

↑