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FDA 510(k)

ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S

K-Number: K001233 · 2000-12-13

ApplicantR-Group Intl.
Decision Date2000-12-13
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S 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 2000-12-13 under 510(k) number K001233. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S?

ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S is a medical device that received FDA 510(k) clearance on 2000-12-13. The listed applicant is R-Group Intl.. The 510(k) number is K001233.

When did ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S receive FDA 510(k) clearance?

ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S received FDA 510(k) clearance on 2000-12-13, under 510(k) number K001233.

Who is the listed applicant for ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S?

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 FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S?

The FDA product code for ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S is FPA.

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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.

K001599ACTI-FLEX IV ADMINISTRATION SETK993777DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESK952470ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.K954035ACTI-FLEX ARTERIAL EXTENSION SETK940319R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINEK913267R-GROUP INTL. ONE WALL PUNCTURE NEEDLE

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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.

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