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FDA 510(k)

MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER

K-Number: K900460 · 1990-07-17

ApplicantNovoste Corp.
Decision Date1990-07-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Novoste Corp.. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K900460. 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 MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER?

MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is Novoste Corp.. The 510(k) number is K900460.

When did MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1990-07-17, under 510(k) number K900460.

Who is the listed applicant for MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER?

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

What is the FDA product code for MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER?

The FDA product code for MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER is DQO.

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 Novoste Corp. 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.

K942977NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICEK911527NOVOSTE GUIDING CATHETERK896690MODIFIED ANGIOGRAPHIC CATHETERK875127NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS

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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