Cleared Special

K111817 - PALINDROME RT CHRONIC CATHETER

K111817 is the FDA 510(k) clearance for PALINDROME RT CHRONIC CATHETER by Covidien. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Special 510(k) pathway after a 64-day FDA review.

K111817 · Covidien · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
64d
Days
Class 2
Risk

K111817 is an FDA 510(k) clearance for the PALINDROME RT CHRONIC CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on August 30, 2011 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Covidien devices

Submission Details

510(k) Number K111817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received June 27, 2011
Decision Date August 30, 2011
Days to Decision 64 days
Submission Type Special
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
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 Peers - MSD Catheter, Hemodialysis, Implanted

All 49
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K111817.
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
K121848 · Medical Components, Inc. · Sep 2012
HEMO-CATH 10F, HEMO-CATH 12.5F
K113487 · Medical Components, Inc. · Mar 2012
SPLIT CATH III
K111651 · Medical Components, Inc. · Dec 2011
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K111900 · Teleflexmedical, Inc. · Aug 2011
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
K111372 · Covidien · Aug 2011
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
K111117 · Teleflexmedical, Inc. · Jun 2011