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)

ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA

K-Number: K892887 · 1989-05-15

ApplicantAkcess Medical Products, Inc.
Decision Date1989-05-15
Product CodeFIQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Akcess Medical Products, Inc.. It received FDA 510(k) clearance on 1989-05-15 under 510(k) number K892887. The device is classified under product code FIQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA?

ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA is a medical device that received FDA 510(k) clearance on 1989-05-15. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K892887.

When did ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA receive FDA 510(k) clearance?

ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA received FDA 510(k) clearance on 1989-05-15, under 510(k) number K892887.

Who is the listed applicant for ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA?

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

What is the FDA product code for ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA?

The FDA product code for ST SERIES SAF-T-SHUNTS ARTERIOVENOUS CANNULA is FIQ.

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 Akcess Medical Products, 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.

K926374SILICONE CATHETER REPAIR KITSK925819AKCESS0CATH KITK925818AKCESS-CATHK930630RIGHT ATRIAL CATHETERK931120COAXIAL ACUTE CATHETERK920634SPLITTABLE SHEATH INTRODUCER SET

View all 36 devices →

Related Devices (Code: FIQ)

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.

K892663S-100 ALLEN-BROWN SHUNTAkcess Medical Products, Inc.K892666SAF-T-SHUNT, S-300 SERIESAkcess Medical Products, Inc.K844692PEDIATRIC SIZED HEMOCATH CATHETERQuinton, Inc.K841791PLUME FISTULA NEEDLEHospal Medical Corp.K840322HEMOFILTRATION CATHETER HF-100Vas-Cath of Canada , Ltd.K840415HEMOCATHQuinton, 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.

↑