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FDA 510(k)

Surefire Spark Infusion System

K-Number: K180677 · 2018-04-03

ApplicantSurefire Medical, Inc.
Decision Date2018-04-03
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surefire Spark Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Surefire Medical, Inc.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K180677. 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 Surefire Spark Infusion System?

Surefire Spark Infusion System is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Surefire Medical, Inc.. The 510(k) number is K180677.

When did Surefire Spark Infusion System receive FDA 510(k) clearance?

Surefire Spark Infusion System received FDA 510(k) clearance on 2018-04-03, under 510(k) number K180677.

Who is the listed applicant for Surefire Spark Infusion System?

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

What is the FDA product code for Surefire Spark Infusion System?

The FDA product code for Surefire Spark Infusion System is DQO.

Other records listing Surefire 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.

K171355Surefire Precision Infusion SystemK162359Surefire Guiding CatheterK160662Surefire Infusion System

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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