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FDA 510(k)

BOLUS DISPENSER

K-Number: K935811 · 1995-01-20

ApplicantI-Flow Corp.
Decision Date1995-01-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BOLUS DISPENSER 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 1995-01-20 under 510(k) number K935811. 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 BOLUS DISPENSER?

BOLUS DISPENSER is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is I-Flow Corp.. The 510(k) number is K935811.

When did BOLUS DISPENSER receive FDA 510(k) clearance?

BOLUS DISPENSER received FDA 510(k) clearance on 1995-01-20, under 510(k) number K935811.

Who is the listed applicant for BOLUS DISPENSER?

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 BOLUS DISPENSER?

The FDA product code for BOLUS DISPENSER 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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