FDA 510(k)

HAGIE PIN

K-Number: K903258 · 1990-08-09

Decision Date1990-08-09

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent for Some Indications

Device Summary

HAGIE PIN is the device name listed in this FDA 510(k) record. The listed applicant is Onyx Medical Corp.. It received FDA 510(k) clearance on 1990-08-09 under 510(k) number K903258. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HAGIE PIN?

HAGIE PIN is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Onyx Medical Corp.. The 510(k) number is K903258.

When did HAGIE PIN receive FDA 510(k) clearance?

HAGIE PIN received FDA 510(k) clearance on 1990-08-09, under 510(k) number K903258.

Who is the listed applicant for HAGIE PIN?

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

What is the FDA product code for HAGIE PIN?

The FDA product code for HAGIE PIN is HWC. This falls under the Cardiovascular category.

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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.