Cleared Traditional

K904334 - PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT

K904334 is an FDA 510(k) clearance for PERCUTANEOUS INTRAVENOUS CATHETER REPAI..., manufactured by Pharmacia Deltec, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K904334 · Pharmacia Deltec, Inc. · General Hospital
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Nov 1990
Decision
45d
Days
Class 2
Risk

K904334 is an FDA 510(k) clearance for the PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 5, 1990 after a review of 45 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 Pharmacia Deltec, Inc. devices

FDA 510(k) Submission Details - K904334

510(k) Number K904334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 21, 1990
Decision Date November 05, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 263
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K904334.
8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
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K910622 · Gesco Intl., Inc. · Mar 1991
VYGON LIFEVAC PICC
K903648 · Vygon Corp. · Mar 1991
WIGNESS-BUCHWALD CENTRAL VENOUS ACCESS CATHETER
K895543 · Strato Medical Corp. · Sep 1990
STRATO INDWELLING CATHETER
K896598 · Strato Medical Corp. · Apr 1990
EPICUTANEO-CAVA CATHETER CODE 2184
K897168 · Vygon Corp. · Apr 1990