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FDA 510(k)

Surefire Precision Infusion System

K-Number: K171355 · 2017-05-17

ApplicantSurefire Medical, Inc.
Decision Date2017-05-17
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surefire Precision Infusion System is a medical device manufactured by Surefire Medical, Inc.. It received FDA 510(k) clearance on 2017-05-17 under approval number K171355. 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 Precision Infusion System?

Surefire Precision Infusion System is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by Surefire Medical, Inc.. The 510(k) number is K171355.

When was Surefire Precision Infusion System approved by the FDA?

Surefire Precision Infusion System received FDA 510(k) clearance on 2017-05-17, under approval number K171355.

What company makes Surefire Precision Infusion System?

Surefire Precision Infusion System is manufactured by Surefire Medical, Inc..

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

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

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT07575191 Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer NOT_YET_RECRUITING NCT05286814 PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma RECRUITING

Other Devices by Surefire Medical, Inc.

K162359Surefire Guiding Catheter K160662Surefire Infusion System K180677Surefire Spark Infusion System

Related Devices (Code: DQO)

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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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