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)

ACTI-FLEX ARTERIAL EXTENSION SET

K-Number: K954035 · 1995-09-25

ApplicantR-Group Intl.
Decision Date1995-09-25
Product CodeCBT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACTI-FLEX ARTERIAL EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is R-Group Intl.. It received FDA 510(k) clearance on 1995-09-25 under 510(k) number K954035. The device is classified under product code CBT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTI-FLEX ARTERIAL EXTENSION SET?

ACTI-FLEX ARTERIAL EXTENSION SET is a medical device that received FDA 510(k) clearance on 1995-09-25. The listed applicant is R-Group Intl.. The 510(k) number is K954035.

When did ACTI-FLEX ARTERIAL EXTENSION SET receive FDA 510(k) clearance?

ACTI-FLEX ARTERIAL EXTENSION SET received FDA 510(k) clearance on 1995-09-25, under 510(k) number K954035.

Who is the listed applicant for ACTI-FLEX ARTERIAL EXTENSION SET?

The FDA 510(k) record lists R-Group Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTI-FLEX ARTERIAL EXTENSION SET?

The FDA product code for ACTI-FLEX ARTERIAL EXTENSION SET is CBT.

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 R-Group Intl. 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.

K001233ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D SK001599ACTI-FLEX IV ADMINISTRATION SETK993777DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESK952470ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.K940319R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINEK913267R-GROUP INTL. ONE WALL PUNCTURE NEEDLE

View all 7 devices →

Related Devices (Code: CBT)

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.

K071269HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K070340SECURE ARTERIAL BLOOD SAMPLING SYSTEMSmiths Medical Asd, Inc.K955663ABC IN-LINE BLOOD SAMPLING KITUtah Medical Products, Inc.K954015ABG POINT LOK NEEDLE PROTECTION DEVICEDevon Industries, Inc.K950098NEEDLE SAFETY COVERHammer-Plane, Inc.K945719ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEMSherwood Medical Co.

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.

↑