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FDA 510(k)

COLS PEEK

K-Number: K113591 · 2011-12-22

ApplicantFournitures Hospitalieres Industrie
Decision Date2011-12-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLS PEEK is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres Industrie. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K113591. 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.

Frequently Asked Questions

What is the COLS PEEK?

COLS PEEK is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Fournitures Hospitalieres Industrie. The 510(k) number is K113591.

When did COLS PEEK receive FDA 510(k) clearance?

COLS PEEK received FDA 510(k) clearance on 2011-12-22, under 510(k) number K113591.

Who is the listed applicant for COLS PEEK?

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

What is the FDA product code for COLS PEEK?

The FDA product code for COLS PEEK is HWC. This falls under the Cardiovascular category.

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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.

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