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FDA 510(k)

CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP

K-Number: K031361 · 2003-05-23

ApplicantDeltec, Inc.
Decision Date2003-05-23
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP is the device name listed in this FDA 510(k) record. The listed applicant is Deltec, Inc.. It received FDA 510(k) clearance on 2003-05-23 under 510(k) number K031361. 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 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP?

CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Deltec, Inc.. The 510(k) number is K031361.

When did CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP receive FDA 510(k) clearance?

CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP received FDA 510(k) clearance on 2003-05-23, under 510(k) number K031361.

Who is the listed applicant for CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP?

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

What is the FDA product code for CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP?

The FDA product code for CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP is FPA.

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Other records listing Deltec, 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.

K030983TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POYK022221TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERSK020655DELTEC INSULIN INFUSION PUMP AND ACCESSORIESK021999GRIPPER PLUS NEEDLE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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