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FDA 510(k)

NFC NEEDLEFREE Y-SITE, MODEL 69970

K-Number: K981547 · 1998-06-18

ApplicantFiltertek, Inc.
Decision Date1998-06-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NFC NEEDLEFREE Y-SITE, MODEL 69970 is the device name listed in this FDA 510(k) record. The listed applicant is Filtertek, Inc.. It received FDA 510(k) clearance on 1998-06-18 under 510(k) number K981547. 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 NFC NEEDLEFREE Y-SITE, MODEL 69970?

NFC NEEDLEFREE Y-SITE, MODEL 69970 is a medical device that received FDA 510(k) clearance on 1998-06-18. The listed applicant is Filtertek, Inc.. The 510(k) number is K981547.

When did NFC NEEDLEFREE Y-SITE, MODEL 69970 receive FDA 510(k) clearance?

NFC NEEDLEFREE Y-SITE, MODEL 69970 received FDA 510(k) clearance on 1998-06-18, under 510(k) number K981547.

Who is the listed applicant for NFC NEEDLEFREE Y-SITE, MODEL 69970?

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

What is the FDA product code for NFC NEEDLEFREE Y-SITE, MODEL 69970?

The FDA product code for NFC NEEDLEFREE Y-SITE, MODEL 69970 is FPA.

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Other records listing Filtertek, 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.

K981548NFC NEEDLEFREE CONNECTOR MODEL 69900K914792PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SETK912848I.V. FILTER EXTENSION SETK912394TRANSDUCER PROTECTORK911451I.V. EXTENDER SETK904912TRANSDUCER PROTECTOR

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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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