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FDA 510(k)

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR

K-Number: K030209 · 2003-05-13

ApplicantThe Kendall Company
Decision Date2003-05-13
Product CodeMPB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR is the device name listed in this FDA 510(k) record. The listed applicant is The Kendall Company. It received FDA 510(k) clearance on 2003-05-13 under 510(k) number K030209. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAHURKAR OPLUS CATHETER, MODEL 13.5 FR?

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR is a medical device that received FDA 510(k) clearance on 2003-05-13. The listed applicant is The Kendall Company. The 510(k) number is K030209.

When did MAHURKAR OPLUS CATHETER, MODEL 13.5 FR receive FDA 510(k) clearance?

MAHURKAR OPLUS CATHETER, MODEL 13.5 FR received FDA 510(k) clearance on 2003-05-13, under 510(k) number K030209.

Who is the listed applicant for MAHURKAR OPLUS CATHETER, MODEL 13.5 FR?

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

What is the FDA product code for MAHURKAR OPLUS CATHETER, MODEL 13.5 FR?

The FDA product code for MAHURKAR OPLUS CATHETER, MODEL 13.5 FR is MPB.

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Other records listing The Kendall Company 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.

K061936KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311K020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRK011283MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGEK011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERSK002901KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

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Related Devices (Code: MPB)

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.

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International CorporationK192807Duo-Flow Side x Side Double Lumen CatheterMedical Components, Inc. (dba MedComp)K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen CatheterCovidien, LLCK163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated

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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