FDA 510(k)

SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T

K-Number: K974457 · 1998-07-14

Decision Date1998-07-14

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K974457. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T?

SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K974457.

When did SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T receive FDA 510(k) clearance?

SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T received FDA 510(k) clearance on 1998-07-14, under 510(k) number K974457.

Who is the listed applicant for SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T?

The FDA product code for SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T is IYO.

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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.