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FDA 510(k)

CARDIOVASCULAR SET UP

K-Number: K850341 · 1985-02-25

ApplicantMarwood Medical, Inc.
Decision Date1985-02-25
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR SET UP is the device name listed in this FDA 510(k) record. The listed applicant is Marwood Medical, Inc.. It received FDA 510(k) clearance on 1985-02-25 under 510(k) number K850341. 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 CARDIOVASCULAR SET UP?

CARDIOVASCULAR SET UP is a medical device that received FDA 510(k) clearance on 1985-02-25. The listed applicant is Marwood Medical, Inc.. The 510(k) number is K850341.

When did CARDIOVASCULAR SET UP receive FDA 510(k) clearance?

CARDIOVASCULAR SET UP received FDA 510(k) clearance on 1985-02-25, under 510(k) number K850341.

Who is the listed applicant for CARDIOVASCULAR SET UP?

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

What is the FDA product code for CARDIOVASCULAR SET UP?

The FDA product code for CARDIOVASCULAR SET UP is DQO.

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Other records listing Marwood Medical, Inc. 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.

K850340EYE PROCEDURE PACKK850338EMERGENCY ROOM PACKK850339SPECIAL PROCEDURES PACKK850337CARDIAC CATHETERIZATION PACKK840620TPN/CVP DRESSING CHANGE KITK840619I.V. START KIT

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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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