FDA 510(k)

HEARTRAIL III GUIDING CATHETER

K-Number: K092372 · 2009-09-11

Decision Date2009-09-11

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEARTRAIL III GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corp.. It received FDA 510(k) clearance on 2009-09-11 under 510(k) number K092372. 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 HEARTRAIL III GUIDING CATHETER?

HEARTRAIL III GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 2009-09-11. The listed applicant is Terumo Corp.. The 510(k) number is K092372.

When did HEARTRAIL III GUIDING CATHETER receive FDA 510(k) clearance?

HEARTRAIL III GUIDING CATHETER received FDA 510(k) clearance on 2009-09-11, under 510(k) number K092372.

Who is the listed applicant for HEARTRAIL III GUIDING CATHETER?

The FDA 510(k) record lists Terumo Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARTRAIL III GUIDING CATHETER?

The FDA product code for HEARTRAIL III GUIDING CATHETER is DQO.

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Other records listing Terumo Corp. as applicant

K100282TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER K091417SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A K090973TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)K073474CAPIOX CIRCUIT CONNECTORS K071572CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER K071494CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER

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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.