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FDA 510(k)

COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET

K-Number: K991985 · 1999-08-20

ApplicantCook, Inc.
Decision Date1999-08-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 1999-08-20 under 510(k) number K991985. 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 COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET?

COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1999-08-20. The listed applicant is Cook, Inc.. The 510(k) number is K991985.

When did COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET receive FDA 510(k) clearance?

COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET received FDA 510(k) clearance on 1999-08-20, under 510(k) number K991985.

Who is the listed applicant for COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET?

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

What is the FDA product code for COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET?

The FDA product code for COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET is FPA.

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Other records listing Cook, 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.

K133634SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SETK132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETERK131201ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SETK131206COOK CERVICAL RIPENING BALLOONK132334TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SETK122091COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY

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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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