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FDA 510(k)

SHELLY PROTECTED AV FISTULA NEEDLE

K-Number: K993187 · 1999-11-05

ApplicantDiasol, Inc.
Decision Date1999-11-05
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHELLY PROTECTED AV FISTULA NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Diasol, Inc.. It received FDA 510(k) clearance on 1999-11-05 under 510(k) number K993187. 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 SHELLY PROTECTED AV FISTULA NEEDLE?

SHELLY PROTECTED AV FISTULA NEEDLE is a medical device that received FDA 510(k) clearance on 1999-11-05. The listed applicant is Diasol, Inc.. The 510(k) number is K993187.

When did SHELLY PROTECTED AV FISTULA NEEDLE receive FDA 510(k) clearance?

SHELLY PROTECTED AV FISTULA NEEDLE received FDA 510(k) clearance on 1999-11-05, under 510(k) number K993187.

Who is the listed applicant for SHELLY PROTECTED AV FISTULA NEEDLE?

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

What is the FDA product code for SHELLY PROTECTED AV FISTULA NEEDLE?

The FDA product code for SHELLY PROTECTED AV FISTULA NEEDLE is FPA.

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Other records listing Diasol, 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.

K020231DIASOL-ADDITIVESK020230DIASOL-BICARBK011004NEEDLELOK HYPODERMIC NEEDLE PROTECTIONK010958FISTULOK FISTULA NEEDLE PROTECTIONK011003SAFESTING AND SAFESTING HUBK992999DAISY PROTECTED SCALP VEIN SET

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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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