Cleared Traditional

V-CATH POLY PICC (K071875) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071875 · Hdc Corp. · General Hospital
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Nov 2007
Decision
122d
Days
Class 2
Risk

K071875 is an FDA 510(k) clearance for the V-CATH POLY PICC. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Hdc Corp. (Milpitas, US). The FDA issued a Cleared decision on November 5, 2007 after a review of 122 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 Hdc Corp. devices

Submission Details

510(k) Number K071875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2007
Decision Date November 05, 2007
Days to Decision 122 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
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K071875.
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
K091324 · C.R. Bard, Inc. · Aug 2009
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
K091670 · Becton, Dickinson & CO · Jul 2009
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K072625 · Cook, Inc. · Dec 2007
POWERPICC SOLO
K072230 · C.R. Bard, Inc. · Oct 2007
4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
K070996 · C.R. Bard, Inc. · May 2007
POWERGROSHONG PICC CATHETER
K063848 · C.R. Bard, Inc. · Apr 2007