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FDA 510(k)

NUMED BALLOON WEDGE PRESSURE CATHETER

K-Number: K864943 · 1987-02-20

ApplicantNuMED, Inc.
Decision Date1987-02-20
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NUMED BALLOON WEDGE PRESSURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 1987-02-20 under 510(k) number K864943. 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 NUMED BALLOON WEDGE PRESSURE CATHETER?

NUMED BALLOON WEDGE PRESSURE CATHETER is a medical device that received FDA 510(k) clearance on 1987-02-20. The listed applicant is NuMED, Inc.. The 510(k) number is K864943.

When did NUMED BALLOON WEDGE PRESSURE CATHETER receive FDA 510(k) clearance?

NUMED BALLOON WEDGE PRESSURE CATHETER received FDA 510(k) clearance on 1987-02-20, under 510(k) number K864943.

Who is the listed applicant for NUMED BALLOON WEDGE PRESSURE CATHETER?

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

What is the FDA product code for NUMED BALLOON WEDGE PRESSURE CATHETER?

The FDA product code for NUMED BALLOON WEDGE PRESSURE CATHETER 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

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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