Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SUREFIRE HI-FLOW MICROCATHETER

K-Number: K121677 · 2012-06-14

ApplicantSurefire Medical, Inc.
Decision Date2012-06-14
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUREFIRE HI-FLOW MICROCATHETER 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 2012-06-14 under 510(k) number K121677. 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 HI-FLOW MICROCATHETER?

SUREFIRE HI-FLOW MICROCATHETER is a medical device that received FDA 510(k) clearance on 2012-06-14. The listed applicant is Surefire Medical, Inc.. The 510(k) number is K121677.

When did SUREFIRE HI-FLOW MICROCATHETER receive FDA 510(k) clearance?

SUREFIRE HI-FLOW MICROCATHETER received FDA 510(k) clearance on 2012-06-14, under 510(k) number K121677.

Who is the listed applicant for SUREFIRE HI-FLOW MICROCATHETER?

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 HI-FLOW MICROCATHETER?

The FDA product code for SUREFIRE HI-FLOW MICROCATHETER is DQO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K180677Surefire Spark Infusion SystemK171355Surefire Precision Infusion SystemK162359Surefire Guiding CatheterK160662Surefire Infusion SystemK122506SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESSK113737SUREFIRE GUIDE SHEATH

View all 8 devices →

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.

↑