Cleared Traditional

K963257 - PERIPHERALLY INSERTED MEDLINE CATHETER

K963257 is an FDA 510(k) clearance for PERIPHERALLY INSERTED MEDLINE CATHETER, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K963257 · Arrow Intl., Inc. · General Hospital
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Mar 1997
Decision
197d
Days
Class 2
Risk

K963257 is an FDA 510(k) clearance for the PERIPHERALLY INSERTED MEDLINE CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 197 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K963257

510(k) Number K963257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date March 04, 1997
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
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 190
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K963257.
SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER
K971085 · B.Braun Medical, Inc. · Jun 1997
PICC CATHETER/MIDLINE CATHETER
K964447 · Menlo Care, Inc. · Apr 1997
HR POLYURETHANE PICC AND MIDLINE CATHETERS
K964556 · Johnson & Johnson Medical, Inc. · Apr 1997
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
K960055 · Pudenz-Schulte Medical Research Corp. · Sep 1996
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · United States Surgical, A Division of Tyco Healthc · Jul 1996
VYGON PREMI-CATH - LONG TERM CATHETER
K954302 · Vygon Corp. · Jun 1996