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FDA 510(k)

ACIST PLUS 4 ANGIOGRAPHIC CATHETER

K-Number: K021015 · 2002-04-26

ApplicantAcist Medical Systems
Decision Date2002-04-26
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACIST PLUS 4 ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems. It received FDA 510(k) clearance on 2002-04-26 under 510(k) number K021015. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIST PLUS 4 ANGIOGRAPHIC CATHETER?

ACIST PLUS 4 ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 2002-04-26. The listed applicant is Acist Medical Systems. The 510(k) number is K021015.

When did ACIST PLUS 4 ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

ACIST PLUS 4 ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 2002-04-26, under 510(k) number K021015.

Who is the listed applicant for ACIST PLUS 4 ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for ACIST PLUS 4 ANGIOGRAPHIC CATHETER?

The FDA product code for ACIST PLUS 4 ANGIOGRAPHIC CATHETER is DQO.

Related Clinical Trials

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Other records listing Acist 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.

K020892ACIST GENTOO CONTRAST INJECTION SYSTEMK991103MODIFICATION TO ACIST CL 100HK000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000K993774ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOHK984058ACIST INJECTOR SYSTEM, MODEL CL100 H

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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