Cleared Traditional

K921352 - VYGON POLYURETHANE VENOUS/ARTERIAL XRO ...

K921352 is an FDA 510(k) clearance for VYGON POLYURETHANE VENOUS/ARTERIAL XRO ..., manufactured by Vygon Corp.. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K921352 · Vygon Corp. · General Hospital
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Oct 1992
Decision
221d
Days
Class 2
Risk

K921352 is an FDA 510(k) clearance for the VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Vygon Corp. (Elizabeth, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 221 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 Vygon Corp. devices

FDA 510(k) Submission Details - K921352

510(k) Number K921352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date October 26, 1992
Days to Decision 221 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 129d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOS Device Classification - Class 2, Special Controls

Product Code FOS Catheter, Umbilical Artery
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 - FOS Catheter, Umbilical Artery

All 21
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K921352.
UMBILI-CATH-S
K940953 · Gesco Intl., Inc. · Aug 1994
UMBILI-CATH-S-DL
K940952 · Gesco Intl., Inc. · Jul 1994
UMBILI-CATH-P
K940871 · Gesco Intl., Inc. · Apr 1994
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · Vygon Corp. · Oct 1992
GESCO UMBILI-CATH
K911607 · Gesco Intl., Inc. · Jun 1991
GESCO DUAL LUMEN UMBILICATH II-DL
K896041 · Gesco Intl., Inc. · Apr 1990