Cleared Traditional

K001901 - POLY PER-Q-CATH PICC CATHETER

K001901 is the FDA 510(k) clearance for POLY PER-Q-CATH PICC CATHETER by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K001901 · C.R. Bard, Inc. · General Hospital
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Sep 2000
Decision
89d
Days
Class 2
Risk

K001901 is an FDA 510(k) clearance for the POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHE.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 2000 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K001901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2000
Decision Date September 19, 2000
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 180
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K001901.
MEDCOMP Z-CATH
K003682 · Medical Components, Inc. · Jan 2001
MEDCOMP BIO-CATH CATHETER LINE
K003110 · Medcomp · Dec 2000
PERIPHERALLY INSERTED CENTRAL CATHETER
K001874 · Utah Medical Products, Inc. · Sep 2000
VYGON 2 FR EPICUTANEO PUR-CATHETER
K993052 · Vygon Corp. · Aug 2000
VYGON LIFECATH-PICC (PUR) CATHETERS (SINGLE AND DOUBLE LUMEN 3FR, 4FR, 4.5FR, AND 5FR)
K993442 · Vygon Corp. · Aug 2000
VYGON DOUBLE LUMEN PICC-CATHETERS (4FR. AND 5FR.)
K983544 · Vygon Corp. · Jan 1999