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FDA 510(k)

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR

K-Number: K053410 · 2006-01-06

ApplicantKendall
Decision Date2006-01-06
Product CodeFEG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kendall. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K053410. The device is classified under product code FEG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR?

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Kendall. The 510(k) number is K053410.

When did GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR receive FDA 510(k) clearance?

GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR received FDA 510(k) clearance on 2006-01-06, under 510(k) number K053410.

Who is the listed applicant for GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR?

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

What is the FDA product code for GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR?

The FDA product code for GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR is FEG.

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Other records listing Kendall 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.

K092797ACUTE AND CHRONIC CATHETER REPAIR KITK06267114.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)K060972KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)K05158414.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORYK043272PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIPK042461KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304

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Related Devices (Code: FEG)

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.

K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd.K132314MEDLINE ANTI-REFLUX VALVEMedline Industries, Inc.K040388NEXT GENERATION SALEM SUMPKendallK971354KNOTT NG TUBEMichael M. Knott, M.D.K960176DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTERC.R. Bard, Inc.K926073ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBESurgimark, Inc.

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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