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FDA 510(k)

ACCU-FLUSH

K-Number: K831637 · 1983-06-30

ApplicantAccu-Line
Decision Date1983-06-30
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCU-FLUSH is the device name listed in this FDA 510(k) record. The listed applicant is Accu-Line. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831637. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-FLUSH?

ACCU-FLUSH is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Accu-Line. The 510(k) number is K831637.

When did ACCU-FLUSH receive FDA 510(k) clearance?

ACCU-FLUSH received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831637.

Who is the listed applicant for ACCU-FLUSH?

The FDA 510(k) record lists Accu-Line as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-FLUSH?

The FDA product code for ACCU-FLUSH is KRA.

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 Accu-Line 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.

K831847JEJUNOSTOMY KITK831636PERCUTANEOUS INTRODUCER KITK830298ACCU-LINE SURGICAL MARKER

Related Devices (Code: KRA)

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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