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)

GlidePath 13F Long-Term Hemodialysis Catheter

K-Number: K211410 · 2021-06-04

Decision Date2021-06-04
Product CodeMSD
Advisory CommitteeGU
DecisionUnknown

Device Summary

GlidePath 13F Long-Term Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2021-06-04 under 510(k) number K211410. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the GlidePath 13F Long-Term Hemodialysis Catheter?

GlidePath 13F Long-Term Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2021-06-04. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K211410.

When did GlidePath 13F Long-Term Hemodialysis Catheter receive FDA 510(k) clearance?

GlidePath 13F Long-Term Hemodialysis Catheter received FDA 510(k) clearance on 2021-06-04, under 510(k) number K211410.

Who is the listed applicant for GlidePath 13F Long-Term Hemodialysis Catheter?

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

What is the FDA product code for GlidePath 13F Long-Term Hemodialysis Catheter?

The FDA product code for GlidePath 13F Long-Term Hemodialysis Catheter is MSD.

Other records listing Bard Peripheral Vascular, Inc. 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.

View all 26 devices →

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.

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.