FDA 510(k)

LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING

K-Number: K053589 · 2006-04-13

Decision Date2006-04-13

Product CodeMSD

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2006-04-13 under 510(k) number K053589. 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 LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING?

LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING is a medical device that received FDA 510(k) clearance on 2006-04-13. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K053589.

When did LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING receive FDA 510(k) clearance?

LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING received FDA 510(k) clearance on 2006-04-13, under 510(k) number K053589.

Who is the listed applicant for LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING?

The FDA product code for LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING is MSD.

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Related Devices (Code: MSD)

K241581Hemodialysis CatheterHaolang Medical USA Corporation K210461End 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.