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)

SPLITTABLE SHEATH INTRODUCER SET

K-Number: K920634 · 1994-01-14

ApplicantAkcess Medical Products, Inc.
Decision Date1994-01-14
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPLITTABLE SHEATH INTRODUCER SET 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 1994-01-14 under 510(k) number K920634. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLITTABLE SHEATH INTRODUCER SET?

SPLITTABLE SHEATH INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1994-01-14. The listed applicant is Akcess Medical Products, Inc.. The 510(k) number is K920634.

When did SPLITTABLE SHEATH INTRODUCER SET receive FDA 510(k) clearance?

SPLITTABLE SHEATH INTRODUCER SET received FDA 510(k) clearance on 1994-01-14, under 510(k) number K920634.

Who is the listed applicant for SPLITTABLE SHEATH INTRODUCER SET?

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 SPLITTABLE SHEATH INTRODUCER SET?

The FDA product code for SPLITTABLE SHEATH INTRODUCER SET is LFJ.

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 CATHETERK914936CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET

View all 36 devices →

Related Devices (Code: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K914162VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERSVas-Cath, 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.

↑