Cleared Traditional

CATH-TECH POLYURETHANE UMBILICAL VESS (K842577) - FDA 510(k) Clearance

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

K842577 · Catheter Technology Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
253d
Days
Class 2
Risk

K842577 is an FDA 510(k) clearance for the CATH-TECH POLYURETHANE UMBILICAL VESS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Catheter Technology Corp. (Salt Lake City, US). The FDA issued a Cleared decision on March 13, 1985 after a review of 253 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Catheter Technology Corp. devices

Submission Details

510(k) Number K842577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date March 13, 1985
Days to Decision 253 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 129d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 110
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K842577.
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · Baxter Healthcare Corp · Jun 1988
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
WINGED CATHETER
K830765 · Abbott Laboratories · Mar 1983
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1981