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FDA 510(k)

PALINDROME H, SI, HSI CHRONIC CATHETER

K-Number: K112477 · 2011-09-28

ApplicantCovidien
Decision Date2011-09-28
Product CodeNYU
Advisory CommitteeGU
DecisionUnknown

Device Summary

PALINDROME H, SI, HSI CHRONIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2011-09-28 under 510(k) number K112477. The device is classified under product code NYU. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PALINDROME H, SI, HSI CHRONIC CATHETER?

PALINDROME H, SI, HSI CHRONIC CATHETER is a medical device that received FDA 510(k) clearance on 2011-09-28. The listed applicant is Covidien. The 510(k) number is K112477.

When did PALINDROME H, SI, HSI CHRONIC CATHETER receive FDA 510(k) clearance?

PALINDROME H, SI, HSI CHRONIC CATHETER received FDA 510(k) clearance on 2011-09-28, under 510(k) number K112477.

Who is the listed applicant for PALINDROME H, SI, HSI CHRONIC CATHETER?

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

What is the FDA product code for PALINDROME H, SI, HSI CHRONIC CATHETER?

The FDA product code for PALINDROME H, SI, HSI CHRONIC CATHETER is NYU.

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Related Devices (Code: NYU)

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Official Source

View on FDA Database →

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