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FDA 510(k)

HOSPIRA CATH LAB CONVENIENCE KITS

K-Number: K052865 · 2005-12-22

ApplicantIcu Medical, Inc.
Decision Date2005-12-22
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOSPIRA CATH LAB CONVENIENCE KITS is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K052865. 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 HOSPIRA CATH LAB CONVENIENCE KITS?

HOSPIRA CATH LAB CONVENIENCE KITS is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Icu Medical, Inc.. The 510(k) number is K052865.

When did HOSPIRA CATH LAB CONVENIENCE KITS receive FDA 510(k) clearance?

HOSPIRA CATH LAB CONVENIENCE KITS received FDA 510(k) clearance on 2005-12-22, under 510(k) number K052865.

Who is the listed applicant for HOSPIRA CATH LAB CONVENIENCE KITS?

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

What is the FDA product code for HOSPIRA CATH LAB CONVENIENCE KITS?

The FDA product code for HOSPIRA CATH LAB CONVENIENCE KITS 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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