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FDA 510(k)

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING

K-Number: K060509 · 2006-06-23

ApplicantTyco Healthcare Group
Decision Date2006-06-23
Product CodeNYU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare Group. It received FDA 510(k) clearance on 2006-06-23 under 510(k) number K060509. The device is classified under product code NYU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING?

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING is a medical device that received FDA 510(k) clearance on 2006-06-23. The listed applicant is Tyco Healthcare Group. The 510(k) number is K060509.

When did PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING receive FDA 510(k) clearance?

PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING received FDA 510(k) clearance on 2006-06-23, under 510(k) number K060509.

Who is the listed applicant for PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING?

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

What is the FDA product code for PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING?

The FDA product code for PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING is NYU.

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Other records listing Tyco Healthcare Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063536POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING

Related Devices (Code: NYU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112477PALINDROME H, SI, HSI CHRONIC CATHETERCovidien

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.

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