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FDA 510(k)

NIPRO DISPOSABLE SOLUTION INFUSION SET

K-Number: K970076 · 1997-03-27

ApplicantNipro Medical Corp.
Decision Date1997-03-27
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NIPRO DISPOSABLE SOLUTION INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corp.. It received FDA 510(k) clearance on 1997-03-27 under 510(k) number K970076. 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 NIPRO DISPOSABLE SOLUTION INFUSION SET?

NIPRO DISPOSABLE SOLUTION INFUSION SET is a medical device that received FDA 510(k) clearance on 1997-03-27. The listed applicant is Nipro Medical Corp.. The 510(k) number is K970076.

When did NIPRO DISPOSABLE SOLUTION INFUSION SET receive FDA 510(k) clearance?

NIPRO DISPOSABLE SOLUTION INFUSION SET received FDA 510(k) clearance on 1997-03-27, under 510(k) number K970076.

Who is the listed applicant for NIPRO DISPOSABLE SOLUTION INFUSION SET?

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

What is the FDA product code for NIPRO DISPOSABLE SOLUTION INFUSION SET?

The FDA product code for NIPRO DISPOSABLE SOLUTION INFUSION SET is FPA.

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Other records listing Nipro Medical 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.

K093985NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLEK081210NIPRO SAFETOUCH HUBER INFUSTION SETK072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693K063368NIPRO BIOHOLE NEEDLEK063721NIPRO SAFETOUCH II GAMMAK052474NIPRO HYPODERMIC NEEDLE

View all 27 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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