Cleared Traditional

K063363 - FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE

K063363 is an FDA 510(k) clearance for FIRMGRIP PERIPHERALLY INSERTED CATHETER..., manufactured by Flexicath , Ltd.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K063363 · Flexicath , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
181d
Days
Class 2
Risk

K063363 is an FDA 510(k) clearance for the FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Flexicath , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on May 7, 2007 after a review of 181 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Flexicath , Ltd. devices

FDA 510(k) Submission Details - K063363

510(k) Number K063363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2006
Decision Date May 07, 2007
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 213
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K063363.
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ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070615 · AngioDynamics, Inc. · May 2007
POWERGROSHONG PICC CATHETER
K063848 · C.R. Bard, Inc. · Apr 2007
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR
K063240 · C.R. Bard, Inc. · Nov 2006