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FDA 510(k)

SUREFIRE GUIDE SHEATH

K-Number: K113737 · 2012-02-23

ApplicantSurefire Medical, Inc.
Decision Date2012-02-23
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUREFIRE GUIDE SHEATH 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 2012-02-23 under 510(k) number K113737. 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 GUIDE SHEATH?

SUREFIRE GUIDE SHEATH is a medical device that received FDA 510(k) clearance on 2012-02-23. The listed applicant is Surefire Medical, Inc.. The 510(k) number is K113737.

When did SUREFIRE GUIDE SHEATH receive FDA 510(k) clearance?

SUREFIRE GUIDE SHEATH received FDA 510(k) clearance on 2012-02-23, under 510(k) number K113737.

Who is the listed applicant for SUREFIRE GUIDE SHEATH?

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 GUIDE SHEATH?

The FDA product code for SUREFIRE GUIDE SHEATH is DQO.

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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, ACCESSK121677SUREFIRE HI-FLOW MICROCATHETER

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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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