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FDA 510(k)

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS

K-Number: K002902 · 2001-04-09

ApplicantThe Kendall Company
Decision Date2001-04-09
Product CodeMSD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS 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 2001-04-09 under 510(k) number K002902. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS?

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is The Kendall Company. The 510(k) number is K002902.

When did TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS receive FDA 510(k) clearance?

TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS received FDA 510(k) clearance on 2001-04-09, under 510(k) number K002902.

Who is the listed applicant for TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS?

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 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS?

The FDA product code for TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS is MSD.

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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 43311K030209MAHURKAR OPLUS CATHETER, MODEL 13.5 FRK020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRK011283MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGEK011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088K002901KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

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Related Devices (Code: MSD)

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.

K241581Hemodialysis CatheterHaolang Medical USA CorporationK210461End CapMedical Components Inc (Medcomp)K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, 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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