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FDA 510(k)

Surefire Guiding Catheter

K-Number: K162359 · 2016-09-21

ApplicantSurefire Medical, Inc.
Decision Date2016-09-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surefire Guiding Catheter 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 2016-09-21 under 510(k) number K162359. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surefire Guiding Catheter?

Surefire Guiding Catheter is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Surefire Medical, Inc.. The 510(k) number is K162359.

When did Surefire Guiding Catheter receive FDA 510(k) clearance?

Surefire Guiding Catheter received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162359.

Who is the listed applicant for Surefire Guiding Catheter?

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 Guiding Catheter?

The FDA product code for Surefire Guiding Catheter is DQY.

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 SystemK160662Surefire Infusion System

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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