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FDA 510(k)

SET, INTRAVASCULAR

K-Number: K881975 · 1988-07-29

ApplicantPrimrose Medical, Inc.
Decision Date1988-07-29
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SET, INTRAVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Primrose Medical, Inc.. It received FDA 510(k) clearance on 1988-07-29 under 510(k) number K881975. 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 SET, INTRAVASCULAR?

SET, INTRAVASCULAR is a medical device that received FDA 510(k) clearance on 1988-07-29. The listed applicant is Primrose Medical, Inc.. The 510(k) number is K881975.

When did SET, INTRAVASCULAR receive FDA 510(k) clearance?

SET, INTRAVASCULAR received FDA 510(k) clearance on 1988-07-29, under 510(k) number K881975.

Who is the listed applicant for SET, INTRAVASCULAR?

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

What is the FDA product code for SET, INTRAVASCULAR?

The FDA product code for SET, INTRAVASCULAR is FPA.

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Other records listing Primrose 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.

K884713COLONIC BALLOON DIALATORSK884714BILIARY DIALATORK884715ACHELASIA BALLOON DIALATORK884711URETHRAL AND URETERAL BALLOON DILATATORSK884712ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884709ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

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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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