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FDA 510(k)

FLEXNEEDLE PLUS

K-Number: K990693 · 1999-05-14

ApplicantAct Medical, Inc.
Decision Date1999-05-14
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLEXNEEDLE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Act Medical, Inc.. It received FDA 510(k) clearance on 1999-05-14 under 510(k) number K990693. 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 FLEXNEEDLE PLUS?

FLEXNEEDLE PLUS is a medical device that received FDA 510(k) clearance on 1999-05-14. The listed applicant is Act Medical, Inc.. The 510(k) number is K990693.

When did FLEXNEEDLE PLUS receive FDA 510(k) clearance?

FLEXNEEDLE PLUS received FDA 510(k) clearance on 1999-05-14, under 510(k) number K990693.

Who is the listed applicant for FLEXNEEDLE PLUS?

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

What is the FDA product code for FLEXNEEDLE PLUS?

The FDA product code for FLEXNEEDLE PLUS is FPA.

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.

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Other records listing Act Medical, 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.

K953967ENDOSCOPIC CATHETER

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

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