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FDA 510(k)

PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS

K-Number: K945617 · 1995-02-13

ApplicantPharma-Plast Intl. A/S
Decision Date1995-02-13
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Plast Intl. A/S. It received FDA 510(k) clearance on 1995-02-13 under 510(k) number K945617. 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 PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS?

PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS is a medical device that received FDA 510(k) clearance on 1995-02-13. The listed applicant is Pharma-Plast Intl. A/S. The 510(k) number is K945617.

When did PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS receive FDA 510(k) clearance?

PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS received FDA 510(k) clearance on 1995-02-13, under 510(k) number K945617.

Who is the listed applicant for PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS?

The FDA 510(k) record lists Pharma-Plast Intl. A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS?

The FDA product code for PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS is FPA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pharma-Plast Intl. A/S 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.

K950178PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET

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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