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FDA 510(k)

INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH

K-Number: K842798 · 1984-08-10

ApplicantAmerican Edwards Laboratories
Decision Date1984-08-10
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1984-08-10 under 510(k) number K842798. 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 INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH?

INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH is a medical device that received FDA 510(k) clearance on 1984-08-10. The listed applicant is American Edwards Laboratories. The 510(k) number is K842798.

When did INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH receive FDA 510(k) clearance?

INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH received FDA 510(k) clearance on 1984-08-10, under 510(k) number K842798.

Who is the listed applicant for INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH?

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

What is the FDA product code for INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH?

The FDA product code for INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH is DQO.

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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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