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FDA 510(k)

STEDIFLO INFUSION SET

K-Number: K832739 · 1983-12-22

ApplicantDravon Medical, Inc.
Decision Date1983-12-22
Product CodeLDR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STEDIFLO INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Dravon Medical, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K832739. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEDIFLO INFUSION SET?

STEDIFLO INFUSION SET is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Dravon Medical, Inc.. The 510(k) number is K832739.

When did STEDIFLO INFUSION SET receive FDA 510(k) clearance?

STEDIFLO INFUSION SET received FDA 510(k) clearance on 1983-12-22, under 510(k) number K832739.

Who is the listed applicant for STEDIFLO INFUSION SET?

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

What is the FDA product code for STEDIFLO INFUSION SET?

The FDA product code for STEDIFLO INFUSION SET is LDR.

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Other records listing Dravon Medical, 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.

K873455S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSISK860770AM-100 I/A AMPACK831842DRAVON T CLAMPK812771PERITONEAL DIALYSIS DRAINAGEK812772PERITONEAL DIALYSIS CYCLER SET (8UNIT)K811851S-610 SHUNT ADAPTOR SET

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Related Devices (Code: LDR)

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.

K242693DEKA Infusion System, DEKA Administration SetDeka Research and Development CorporationK232316DEKA Infusion System, DEKA Administration SetDeka Research and DevelopmentK153760Volumetric Infusion ControllerDEKA Research & DevelopmentK963136PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.K971826ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500Alexander Mfg. Co.K971865ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3PAlexander Mfg. Co.

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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