Cleared Traditional

K071361 - R4 VASCULAR INC. PEGASUS CT PICC

K071361 is an FDA 510(k) clearance for R4 VASCULAR INC. PEGASUS CT PICC, manufactured by R4 Vascular, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K071361 · R4 Vascular, Inc. · General Hospital
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Aug 2007
Decision
97d
Days
Class 2
Risk

K071361 is an FDA 510(k) clearance for the R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001,.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by R4 Vascular, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 20, 2007 after a review of 97 days - within the typical 510(k) review window.

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 R4 Vascular, Inc. devices

FDA 510(k) Submission Details - K071361

510(k) Number K071361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2007
Decision Date August 20, 2007
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
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 191
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K071361.
V-CATH POLY PICC
K071875 · Hdc Corp. · Nov 2007
POWERPICC SOLO
K072230 · C.R. Bard, Inc. · Oct 2007
ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
K072196 · AngioDynamics, Inc. · Aug 2007
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
K070002 · Boston Scientific · Aug 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070613 · AngioDynamics, Inc. · Jun 2007
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
K070996 · C.R. Bard, Inc. · May 2007