Cleared Traditional

K944685 - CATO FIRST PICC-DUAL LUMEN

K944685 is an FDA 510(k) clearance for CATO FIRST PICC-DUAL LUMEN, manufactured by Catco Medical, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K944685 · Catco Medical, Inc. · General Hospital
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Mar 1995
Decision
190d
Days
Class 2
Risk

K944685 is an FDA 510(k) clearance for the CATO FIRST PICC-DUAL LUMEN. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Catco Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 31, 1995 after a review of 190 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 Catco Medical, Inc. devices

FDA 510(k) Submission Details - K944685

510(k) Number K944685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1994
Decision Date March 31, 1995
Days to Decision 190 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 129d · This submission: 190d
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 275
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K944685.
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
K945956 · Strato Medical Corp. · Jun 1995
HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER
K951098 · Hdc Corp. · Jun 1995
STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
K946250 · Strato Medical Corp. · May 1995
VASCULAR ACCESS CATHETER ACCESSORIES
K935380 · Bard Access Systems, Inc. · Feb 1995
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K932198 · Pharmacia Deltec, Inc. · May 1994
PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS
K932211 · Pharmacia Deltec, Inc. · May 1994