Cleared Traditional

K063355 - D-LINE CATHETER ST, DOUBLE LUMEN ST

Also marketed or referenced as:
EXTRA FLOW

K063355 is an FDA 510(k) clearance for D-LINE CATHETER ST, manufactured by Novosci Corp.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K063355 · Novosci Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
262d
Days
Class 2
Risk

K063355 is an FDA 510(k) clearance for the D-LINE CATHETER ST, DOUBLE LUMEN ST. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Novosci Corp. (The Woodlands, US). The FDA issued a Cleared decision on July 27, 2007 after a review of 262 days - an extended review cycle.

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. Standard predicate reliance. 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 Novosci Corp. devices

FDA 510(k) Submission Details - K063355

510(k) Number K063355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 07, 2006
Decision Date July 27, 2007
Days to Decision 262 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
131d slower than avg
Panel avg: 131d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-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 - MPB Catheter, Hemodialysis, Non-implanted

All 32
Devices cleared under the same product code (MPB) and FDA review panel - the closest regulatory comparables to K063355.
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
K110793 · Ameco Medical Industries · Dec 2011
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
K090102 · C.R. Bard, Inc. · Feb 2009
NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE
K071145 · Nipro Medical Corporation · Sep 2007
JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
K070234 · Jms North America Corp. · May 2007
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
K040301 · Gambro Renal Products · Nov 2004
NIAGARA TEMPORARY DUAL LUMEN CATHETERS
K030268 · C.R. Bard, Inc. · Jul 2003