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FDA 510(k)

HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO

K-Number: K991513 · 1999-06-21

ApplicantI-Flow Corp.
Decision Date1999-06-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO is the device name listed in this FDA 510(k) record. The listed applicant is I-Flow Corp.. It received FDA 510(k) clearance on 1999-06-21 under 510(k) number K991513. 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 HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO?

HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO is a medical device that received FDA 510(k) clearance on 1999-06-21. The listed applicant is I-Flow Corp.. The 510(k) number is K991513.

When did HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO receive FDA 510(k) clearance?

HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO received FDA 510(k) clearance on 1999-06-21, under 510(k) number K991513.

Who is the listed applicant for HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO?

The FDA 510(k) record lists I-Flow Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO?

The FDA product code for HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO 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 I-Flow Corp. 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.

K063530ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMPK063234ON-Q INTRODUCERSK051401ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETERK052117I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)K043456MODIFICATION TO SOAKER CATHETERK040337I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)

View all 41 devices →

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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