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FDA 510(k)

RINSPIRATION SYSTEM

K-Number: K031485 · 2003-09-25

ApplicantKerberos Proximal Solutions
Decision Date2003-09-25
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RINSPIRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kerberos Proximal Solutions. It received FDA 510(k) clearance on 2003-09-25 under 510(k) number K031485. 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 RINSPIRATION SYSTEM?

RINSPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-25. The listed applicant is Kerberos Proximal Solutions. The 510(k) number is K031485.

When did RINSPIRATION SYSTEM receive FDA 510(k) clearance?

RINSPIRATION SYSTEM received FDA 510(k) clearance on 2003-09-25, under 510(k) number K031485.

Who is the listed applicant for RINSPIRATION SYSTEM?

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

What is the FDA product code for RINSPIRATION SYSTEM?

The FDA product code for RINSPIRATION SYSTEM 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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