Cleared Traditional

K190527 - GlidePath Long-Term Hemodialysis Catheters

K190527 is the FDA 510(k) clearance for GlidePath Long-Term Hemodialysis Catheters by C. R. Bard. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K190527 · C. R. Bard · Gastroenterology & Urology device
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Mar 2020
Decision
367d
Days
Class 2
Risk

K190527 is an FDA 510(k) clearance for the GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis C.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by C. R. Bard (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 5, 2020 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C. R. Bard devices

Submission Details

510(k) Number K190527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 04, 2019
Decision Date March 05, 2020
Days to Decision 367 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 130d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Bard Access Systems, Inc.
Joan Bergstrom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MSD Catheter, Hemodialysis, Implanted

All 63
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K190527.
GlidePath 7.5F Long-Term Dialysis Catheter
K202150 · C.R. Bard, Inc. · Nov 2020
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
K202176 · Medical Components, Inc. (dba MedComp) · Sep 2020
GlidePath 10F Long-Term Dialysis Catheter
K200627 · C.R. Bard, Inc. · Jun 2020
Pristine Hemodialysis Catheter
K182443 · Pristine Access Technologies , Ltd. · May 2019
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
K173667 · Medical Components, Inc. (dba MedComp) · May 2018
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)
K173805 · Marvao Medical Devices, Ltd. · Feb 2018