Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACUTE AND CHRONIC CATHETER REPAIR KIT

K-Number: K092797 · 2009-11-19

ApplicantKendall
Decision Date2009-11-19
Product CodeNFK
Advisory CommitteeGU
DecisionUnknown

Device Summary

ACUTE AND CHRONIC CATHETER REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kendall. It received FDA 510(k) clearance on 2009-11-19 under 510(k) number K092797. The device is classified under product code NFK. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ACUTE AND CHRONIC CATHETER REPAIR KIT?

ACUTE AND CHRONIC CATHETER REPAIR KIT is a medical device that received FDA 510(k) clearance on 2009-11-19. The listed applicant is Kendall. The 510(k) number is K092797.

When did ACUTE AND CHRONIC CATHETER REPAIR KIT receive FDA 510(k) clearance?

ACUTE AND CHRONIC CATHETER REPAIR KIT received FDA 510(k) clearance on 2009-11-19, under 510(k) number K092797.

Who is the listed applicant for ACUTE AND CHRONIC CATHETER REPAIR KIT?

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 ACUTE AND CHRONIC CATHETER REPAIR KIT?

The FDA product code for ACUTE AND CHRONIC CATHETER REPAIR KIT is NFK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K06267114.5 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)K053410GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTORK05158414.5 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

View all 12 devices →

Related Devices (Code: NFK)

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.

K101261CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K063446CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K062435REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERSSpire Biomedical, Inc.K030442CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000C.R. Bard, Inc.K022644RETRO REPAIR KIT, MODEL PRRK5Spire Biomedical, Inc.K022570MEDCOMP REPAIR KIT, MODEL ASPCRPKMedcomp

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.

↑