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FDA 510(k)

SMARTSITE ACCESS PIN

K-Number: K970485 · 1997-04-21

ApplicantIvac Medical Systems
Decision Date1997-04-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTSITE ACCESS PIN is the device name listed in this FDA 510(k) record. The listed applicant is Ivac Medical Systems. It received FDA 510(k) clearance on 1997-04-21 under 510(k) number K970485. 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 SMARTSITE ACCESS PIN?

SMARTSITE ACCESS PIN is a medical device that received FDA 510(k) clearance on 1997-04-21. The listed applicant is Ivac Medical Systems. The 510(k) number is K970485.

When did SMARTSITE ACCESS PIN receive FDA 510(k) clearance?

SMARTSITE ACCESS PIN received FDA 510(k) clearance on 1997-04-21, under 510(k) number K970485.

Who is the listed applicant for SMARTSITE ACCESS PIN?

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

What is the FDA product code for SMARTSITE ACCESS PIN?

The FDA product code for SMARTSITE ACCESS PIN 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 Ivac Medical Systems 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.

K961486IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT

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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