Cleared Special

K073451 - PRESSURE INJECTABLE PICC

K073451 is an FDA 510(k) clearance for PRESSURE INJECTABLE PICC, manufactured by Arrow International, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Special 510(k) pathway after a 36-day FDA review.

K073451 · Arrow International, Inc. · General Hospital
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Jan 2008
Decision
36d
Days
Class 2
Risk

K073451 is an FDA 510(k) clearance for the PRESSURE INJECTABLE PICC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Arrow International, Inc. (Reading, US). The FDA issued a Cleared decision on January 15, 2008 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital 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 Arrow International, Inc. devices

FDA 510(k) Submission Details - K073451

510(k) Number K073451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2007
Decision Date January 15, 2008
Days to Decision 36 days
Submission Type Special
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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

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 242
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K073451.
PICC (CT RATED AND NON-RATED)
K083873 · Pfm Medical, Inc. · Mar 2009
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
K081904 · Medcomp · Sep 2008
PRESSURE INJFECTABLE PICC
K080604 · Arrow International, Inc. · Jun 2008
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · Cook, Inc. · Dec 2007
PRO-PICC, BASIC TRAY
K072509 · Medcomp · Nov 2007
PFM PICC
K072391 · Pfm Medical, Inc. · Nov 2007